Infinity M300 PWT
The Infinity M300 is a patient-worn transceiver for ECG and pulse oximetry monitoring in adult and pediatric patients. It communicates wirelessly over the Infinity patient monitoring…
The Infinity M300 is a patient-worn transceiver for ECG and pulse oximetry monitoring in adult and pediatric patients. It communicates wirelessly over the Infinity patient monitoring network with an Infinity CentralStation, which serves as the primary monitoring display and alarm source. It can monitor ambulatory and non-ambulatory patients.
The M300 provides continuous ECG monitoring with heart rate, arrhythmia and ST-segment analysis, along with oxygen saturation, pulse rate and a pulse plethysmogram waveform. Its own color display shows measurements, waveforms and alarms. A rechargeable battery powers the transceiver.
Use and Charging
The M300 is used on one patient at a time. Its battery can be charged with a bedside or central charger. It is not compatible with use in an MRI magnetic field.
9manufacturers in China registered for this device type
1catalogue number
25510(k) clearances naming this product code
22recalls on this code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Draeger Medical Systems, Inc., United States |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K130711 |
| Record published | 2015-10-24 |
| Record revised | 2021-11-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS18623 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260579 | 2026-08-20 |
| K240312 | 2024-08-01 |
| K231477 | 2023-10-17 |
| K203088 | 2022-02-01 |
| K201764 | 2021-12-09 |
| K200859 | 2020-08-28 |
| K151860 | 2015-09-02 |
| K130711 | 2013-04-11 |
| K113798 | 2012-03-22 |
| K093788 | 2010-03-08 |
| K070566 | 2007-06-04 |
| K061379 | 2007-02-16 |
| K060039 | 2006-04-12 |
| K060223 | 2006-04-12 |
| K053484 | 2006-02-22 |
| K051658 | 2005-11-16 |
| K051628 | 2005-07-20 |
| K043439 | 2005-02-18 |
| K042904 | 2005-02-18 |
| K043549 | 2005-01-21 |
| K042656 | 2004-10-06 |
| K033957 | 2004-05-14 |
| K041087 | 2004-05-12 |
| K033694 | 2004-03-22 |
| K033600 | 2003-12-11 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Draeger Medical Systems, Inc. | 510(k) number | 2022-03-04 | Class II | Software design | Software issue resulting in temporary loss of central monitoring functionality. | 1950 (1574 OUS + 376 US) |
| Draeger Medical Systems, Inc. | 510(k) number | 2019-10-09 | Class II | Software design | The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. | 12204 |
Recalls
16 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-01-14 | Class II | Device Design | Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient. | 1,013 units | |
| 2024-05-13 | Class II | Device Design | Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia. | 34,102 units | |
| 2023-04-05 | Class II | Software design | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency | 19,429 systems | |
| 2023-04-05 | Class II | Software design | The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency | 6803 systems | |
| 2020-12-23 | Class II | Software design | The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device | 19802 systems (Domestic: 3412, Foreign 16,390) | |
| 2019-09-13 | Class II | Software design | Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. | 5634 | |
| 2019-02-08 | Class II | Software design | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication. | 10699 in total | |
| 2019-02-08 | Class II | Software design | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication. | 10699 in total | |
| 2018-03-28 | Class II | Under Investigation by firm | Software anomaly resulting in the loss of patient settings and stored patient data. | 25, 629 | 2020-04-21 |
| 2018-02-21 | Class II | Software Manufacturing/Software Deployment | The invasive pressure visual and audible alarms may not activate. | 28317 total products | 2020-04-20 |
| 2017-10-04 | Class II | Nonconforming Material/Component | Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Drger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value | 2,760 | 2018-06-15 |
| 2017-06-06 | Class II | Software design | Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station. | 37 US and 682 OUS | 2018-06-19 |
| 2017-03-28 | Class II | Under Investigation by firm | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. | 2,156 (total for all devices) | 2018-09-17 |
| 2017-03-28 | Class II | Under Investigation by firm | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. | 2,156 (total for all devices) | 2018-09-17 |
| 2017-03-28 | Class II | Under Investigation by firm | It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. | 2,156 (total for all devices) | 2018-09-17 |
| 2013-12-10 | Class II | Software design | After a test in which a low SpO2 (yellow) medium grade alarm initiated in neo-natal mode and was subsequently paused, the high grade life threatening SpO2 alarm (red) did not activate when the SpO2 values were decreased to reach the red ala | 439 | 2015-05-20 |
| 2011-07-29 | Not classified | Device Design | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. | 32 | 2012-08-16 |
| 2011-07-29 | Not classified | Device Design | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. | 29 | 2012-08-16 |
| 2010-06-04 | Not classified | Device Design | Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically. | 8675 units | 2012-07-30 |
| 2010-06-04 | Not classified | Device Design | Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically. | 800 units | 2012-07-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.