Infinity M540 MS26372Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04049098009751), received between Oct 6, 2023 and Feb 28, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 reports).

2 FDA recall records name this device's identifier.

6 other recalls cover devices cleared under the same FDA submission (K113798); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 28, 2018Terminated

   Software anomaly resulting in the loss of patient settings and stored patient data.

   Z-1813-2018 · Root cause: Under Investigation by firm · FDA record ↗

2. Feb 21, 2018Terminated

   The invasive pressure visual and audible alarms may not activate.

   Z-1382-2018 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2025High Sensing Threshold; Device Sensing Problem; High Sensing Threshold; Device Sensing Problem

  IT WAS REPORTED THE M540 MONITOR HAS DIFFICULTIES OBTAINING A NIBP MEASUREMENT WITH A NEONATAL PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER MONITOR TO OBTAIN A READING. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21494326 ↗
• MalfunctionSep 13, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED BY THE CUSTOMER THAT THE M540 HAS SHUT DOWN DURING OPERATION AND GAVE AN ALARM AND COULD NOT BE RESTARTED. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212894 ↗
• MalfunctionAug 15, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT A C500 AND M540 DISCONNECTED, RESULTING IN THE USERS TO SWAP OUT THE M540 TO CONTINUE PATIENT TREATMENT. THE PATIENT WAS IN OR 4 UNDERGOING ELECTRO-SURGERY AT THE TIME. THE COCKPIT DISPLAYED "DISCONNECTED FROM M540" THE USER PULLED THE M540 POWERED OFF AND BACK ON AND MOVED IT TO ANOTHER ROOM AND IT CONTINUED TO DISPLAY DISCONNECTED FROM M540. THE USER THEN POWERED THE UNIT OFF AND BACK ON AND THE UNIT CONNECTED. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992699 ↗
• MalfunctionMay 7, 2024Capturing Problem; Unexpected Shutdown; Capturing Problem; Unexpected Shutdown

  THERE WAS NO SPECIFIC EVENT REPORTED - THE USER FACILITY STATED THAT THEY WERE UNABLE TO ESTABLISH 12-LEAD ECG MONITORING FOR CRITICAL PATIENTS PROPERLY. THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT HEALTH CONSEQUENCES FOR A PATIENT MAY HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261581 ↗
• MalfunctionApr 25, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT ON STANDALONE M540, THE SPO2 WAVEFORM AND NUMERIC VALUES DROPPED ON 03/28 AT 10:30 AM WHILE USING MASIMO RAINBOW PODS ON A NEONATAL PATIENT. IT WAS REPORTED THAT THE M540 WOULD DISPLAY THAT IT WAS "SEARCHING" FOR AN SP02 VALUE, BUT THAT THE WAVEFORM WOULD FLATLINE AND NO NUMERICAL VALUES COULD BE SHOWN. NO PATIENT INJURY OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19181875 ↗
• MalfunctionMar 21, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT, TO PROVIDE POWER TO A MONITOR WITH LOW BATTERY, THE NURSE RECEIVED AN ELECTRIC SHOCK TO THE RIGHT HAND WHILE PLUGGING THE M540 INTO THE M500. THE M540 IMMEDIATELY DISCONNECTED FROM THE PATIENT, AND A LEAKAGE CURRENT ALARM WENT OFF IN THE ROOM. THE POWERCORD WAS FOUND TO HAVE SOME BURN MARKS. THE NURSE FELT A TINGLE/NUMBNESS IN THE RIGHT HAND. THEY VISITED THE ER WHERE VITALS TAKEN THERE FOR FOLLOW-UP, EKG, TNT AND CK SHOWED NORMAL. DURING THE EVENING AT HOME ON THE RIGHT SIDE OF THE BODY (ARM AND LEG) NUMBNESS/ IMPOTENCE OF KNOWLEDGE. THE NEXT MORNING THE FEELING STRONGER, BUT THEN SUBSIDED LATER THE NEXT DAY.

  Patient problems: Numbness

  MAUDE report 18950389 ↗
• MalfunctionMar 12, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT THE M540 WAS NOT CORRECTLY READING AN INFANT'S O2 SATURATIONS. THE M540 SHOWED THAT THE INFANT HAD A O2 SATURATION OF 37%, HOWEVER; THE PATIENT WAS AWAKE AND CONSCIOUS, WITH A NORMAL HEART RATE AND NOT SHOWING LOW O2 SYMPTOMS. THE CUSTOMER REPLACED THE O2 SATURATION PROBE, AND THE READING REMAINED THE SAME. THE BIOMED STATED THAT THERE IS NO EVENT PATIENT INFORMATION AS THE DEVICES WERE RECEIVED ON THEIR DESK WITH NO ADDITIONAL INFORMATION. THERE IS NO INFORMATION STATING THERE IS ANY ADVERSE PATIENT IMPACT OR DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889720 ↗
• MalfunctionFeb 22, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THE M540 WAS NOT GIVING EKG READINGS. THE M540 WAS SWAPPED OUT - APPROX 30 SECONDS IN DELAY TO PATIENT TREATMENT WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18757152 ↗
• MalfunctionOct 6, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING AN ONGOING CPR THE PATIENT MONITORING SYSTEM FAILED TO PROVIDE ECO2 DATA WHICH MADE CLINICAL DECISIONS IN THIS SITUATION MORE CHALLENGING. IT WAS CONFIRMED THE RESUSCITATION WAS SUCCESSFUL THAT THE PATIENT WAS TRANSFERRED TO THE ICU.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17884010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113798. One submission often covers many models, so check the product and lot details in each record.

• Z-1104-2021 · Dec 23, 2020 · Open, Classified
  Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in enviro
• Z-0258-2020 · Sep 13, 2019 · Open, Classified
  The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
• Z-0942-2018 · Oct 4, 2017 · Terminated
  INFINITY DUAL HEMO MCable Pod
• Z-2734-2017 · Jun 6, 2017 · Terminated
  Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
• Z-0714-2014 · Dec 10, 2013 · Terminated
  Draeger Infinity Acute Care System Monitoring Solution
• Z-0939-2013 · Dec 13, 2012 · Terminated
  Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.