SHP UNT M300 PWT WPA2 MS25755Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04049098048989), received between Nov 19, 2021 and Dec 27, 2023 — classified as 4 deaths, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K130711); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 5, 2023Class IIOpen, Classified

   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 QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

   Z-1472-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathDec 27, 2023No Audible Prompt/Feedback; Adverse Event Without Identified Device or Use Problem; No Audible Prompt/Feedback; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS MONITORED WITH A TELEMETRY DEVICE; THE HEART RATE DISPLAYED AT THE CENTRAL MONITORING STATION (CMS) WAS 86BPM. A NURSE WAS WITH THE PATIENT UNTIL 9:10 PM. THE PATIENT HAD A HEART ATTACK WITHIN THE NEXT FEW MINUTES; THE BED NEIGHBOR CALLED THE NURSE AT 9:14. UNFORTUNATELY, THE INITIATED RESUSCITATION EFFORTS WERE NOT SUCCESSFUL, THE PATIENT DIED.

  Patient problems: Cardiac Arrest

  MAUDE report 18397123 ↗
• InjuryDec 20, 2023No Audible Prompt/Feedback; Communication or Transmission Problem; No Audible Prompt/Feedback; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT LEFT THE WARD ON THE DOE AT APPROX. 5AM. THE PATIENT WAS FOUND ON THE FLOOR IN THEIR ROOM BETWEEN 7 AND 8AM AND IN NEED OF RESUSCITATION. AFTER RE-ENTERING THE WARD, THE M300 OBVIOUSLY DID NOT GO ONLINE AGAIN. PATIENT IS IN THE INTENSIVE CARE UNIT; ACCORDING TO THE DOCTOR, THE PATIENT HAS NOT SUFFERED ANY FURTHER DAMAGE AS A RESULT OF THIS INCIDENT.

  Patient problems: Arrhythmia

  MAUDE report 18363926 ↗
• MalfunctionNov 7, 2023Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THE BATTERY RUNTIME WAS SIGNIFICANTLY REDUCED AND THAT THE DEVICE WAS PRODUCING FALSE-POSITIVE ALARMS. THERE WAS NO PATIENT INJURY ASSOCIATED TO THAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083735 ↗
• DeathMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WENT INTO ASYSTOLE WHILE THE INFINITY M300 WAS IN STANDBY AND THE PATIENT PASSED AWAY. NO ALARMS WERE ISSUED BECAUSE THE M300 WAS IN STANDBY. THOUGH THERE WAS NO ALLEGATION THE DEVICE CAUSE OR CONTRIBUTED TO THE PATIENT OUTCOME, THIS CASE REPRESENTS A USE ERROR OF THE DEVICE DURING AN EVENT WHERE THE INVOLVED PATIENT DIED. THE DEVICE WAS INADVERTENTLY LEFT IN STANDBY MODE RESULTING IN THE DEVICE NOT PROVIDING AN ASYSTOLE ALARM. THE INFINITY M300 PATIENT WORN MONITOR IS USED WITH THE INFINITY CENTRAL STATION (ICS). STANDBY MODE IS USED TO TEMPORARILY INTERRUPT PATIENT MONITORING. THIS MAY BE USED WHEN A PATIENT IS TAKING A SHOWER OF TAKEN OFF UNIT FOR A PROCEDURE/IMAGING, ETC. FOR THE M300, STANDBY MODE CAN ONLY BE ENABLED FROM THE ICS. WHEN STANDBY MODE IS ENABLED, THE USER MUST SELECT THE DURATION (5 MINUTES, 10 MINUTES, 20 MINUTES, 30 MINUTES, 1 HOUR, 2 HOURS, 3 HOURS). THE DEFAULT SETTING IS 1 HOUR. STANDBY MODE HAS THE FOLLOWING EFFECT: THE STANDBY BANNER IS DISPLAYED IN THE WAVEFORM AREA OF THE ICS MAIN SCREEN, IN THE BED-VIEW OF THE PATIENT AND IN THE BED¿S HEADER BARS. THE STANDBY BANNER APPEARS AT THE M300. WITH THE EXCEPTION OF OFFLINE ALARMS

  Patient problems: Cardiac Arrest

  MAUDE report 16641779 ↗
• DeathNov 28, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT WAS FOUND DEAD IN THE ROOM WITH AN INFINITY M300 DEVICE, WITH BATTERY INSTALLED AND ELECTRODES WERE ALL PROPERLY ATTACHED TO THE PATIENT. THE PATIENT WAS FOUND DURING THE LAST ROUNDS OF THE LATE SHIFT. THE PATIENT ALREADY HAD DEATH MARKS, THE M300 DID NOT ALARM AND DESPITE THE DEATH MARKS, THE M300 DISPLAYED A PULSE OF 21. IT WAS NOTED THAT THE INFINITY CENTRAL STATION (ICS) PROVIDED A HF ALARM AND THAT AT THE TIME OF THE INCIDENT, THE STAFF WAS IN THE NURSING ROUND AND THEREFORE DID NOT HEAR THE ALARM. NOTE THAT THE INFINITY M300 GENERATES ALARMS AND PROVIDES THEM T THE ICS THROUGH THE NETWORK.

  Patient problems: Diminished Pulse Pressure

  MAUDE report 15868703 ↗
• DeathAug 2, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THAT AN INCIDENT OCCURRED WHERE IS WAS ALLEGED THAT THE INFINITY CENTRAL STATION (ICS) DID NOT PROVIDE AN ALARM. MANUAL CPR WAS PROVIDED HOWEVER, THE INVOLVED PATIENT DIED. THE DRAEGER INFINITY M300 PATIENT WORN MONITOR IS USED WITH THE INFINITY CENTRAL STATION (ICS). THE M300 PROVIDES ALARMS TO THE ICS. (INVOLVED M300 SERIAL NUMBER (B)(4) AND ASSOCIATED ICS SERIAL NUMBER (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15153540 ↗
• MalfunctionNov 19, 2021Fire; Fire

  IT WAS REPORTED THAT: WHEN THE NURSE WAS WALKING BY THE CENTRAL CHARGER A M300 ¿[BATTERY] EXPLODED AND CAUGHT ON FIRE" IN THE CHARGER (I CONFIRMED IT WAS THE CENTRAL [10 DOCK] CHARGER) AND WAS EMANATING BLACK SMOKE¿ ¿ THERE ¿WAS SHRAPNEL¿ ON THE FLOOR. THERE WAS NO PATIENT INVOLVEMENT, HOWEVER IT WAS CONVEYED BY THE RISK MANAGER THAT THE NURSE WAS BURNED (A PIN-POINT) ON THE HAND. ADDITIONALLY, THE M300 NEXT TO THE ONE THAT CAUGHT ON FIRE WAS ALSO DAMAGED. AS PER THE BIOMED, THERE WAS NO EVACUATION NOR WAS THE FIRE DEPARTMENT - IT WAS CONTAINED BY THE STAFF. QUALITY CONTACTED THE RISK MANAGER AND THE FOLLOWING IS A SUMMARY TO DATE OF THE INFORMATION RECEIVED FROM THE INCIDENT: CALLED TO RM: (B)(6) / 2 M300 / 1 CC CHARGER : 1. THE M300 BATTERY EXPLODED SENDING DEBRIS ALL OVER THE ROOM - QUALITY JUST LEARNED THIS 10/25 - NOT THE M300 ENTIRELY. 2. THE M300 NEXT TO THE ONE THAT EXPLODED WAS ALSO DAMAGED. 3. THE RM WORDS WERE "IT WAS LIKE A BOMB GOING OFF" THE NURSE WAS BURNED ON HER HAND - A "PIN POINT BURN", PER (B)(6). 4. THE FLOOR AND COUNTERTOP WERE BOTH BURNED. 5. ALL M300S WERE REMOVED FROM SERVICE AS (B)(6) IS REQUESTING THEY ALL BE PM'D BEFORE RETURNING TO SERVICE. 6. THE M300S

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 12849013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130711. One submission often covers many models, so check the product and lot details in each record.

• Z-1012-2022 · Mar 4, 2022 · Open, Classified
  Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
• Z-0372-2020 · Oct 9, 2019 · Open, Classified
  Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301