SHP UNT INFINITY M540 MS20401Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 04049098054454), received between Sep 16, 2021 and Aug 4, 2026 — classified as 5 deaths, 5 injuries, 52 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 28, 2018Class IITerminated

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

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

2. Feb 21, 2018Class IITerminated

   The invasive pressure visual and audible alarms may not activate.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• DeathAug 4, 2026Device Alarm System; Output Problem

  It was reported that on the night of Friday, (b)(6), between 3:00 a.m. and 5:00 a.m., a patient died without any event being reported to the ICS monitoring center "[Infinity Central station (ICS)]". The nurses checked the patient¿s vital signs around 3:00 a.m. and then returned to the patient around 5:00 a.m., at which time they confirmed the patient¿s death. According to the available information, no alarm was triggered or displayed on the monitoring console "[Infinity Acute Care System (IACS)]" during that time.

  Patient problems: Insufficient Information

  MAUDE report 50133037 ↗
• MalfunctionJun 24, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE M540 MONITOR SCREEN FROZE WHILE IN USE ON A PATIENT. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607904 ↗
• MalfunctionApr 13, 2026Electrical /Electronic Property Problem; No Audible Prompt/Feedback; Output Problem

  IT WAS REPORTED THE INFINITY M540 MONITOR DID NOT EMIT AN AUDIBLE ALARM. THE VISUAL ALARM WORKED AS EXPECTED. NO ADVERSE PATIENT IMPACT WAS REPORTED.

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

  MAUDE report 24861587 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem; No Audible Prompt/Feedback; Output Problem

  THE CUSTOMER REPORTED THE M540 MONITOR DID NOT EMIT AN AUDIBLE WARNING SIGNAL, EVEN THOUGH IT HAD NOT BEEN MUTED. THE STAFF ONLY BECAME AWARE OF THE ALARM BECAUSE OF THE SIMULTANEOUS VISUAL SIGNAL. THERE WAS NO ADVERSE PATIENT IMPACT, AS THE ALARM CONDITION WAS DETECTED IN TIME.

  Patient problems: Insufficient Information

  MAUDE report 24701071 ↗
• MalfunctionFeb 19, 2026Unexpected Shutdown

  IT WAS REPORTED THE M540 PATIENT MONITOR AND C500 COCKPIT DISPLAY POWERED OFF DURING A CASE. THE DOCTOR HAD TO PHYSICALLY PRESS THE POWER BUTTONS TO TURN BACK ON. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393249 ↗
• MalfunctionDec 16, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS AN INTERMITTENT INABILITY TO OBTAIN (NIBP) NON-INVASIVE BLOOD PRESSURE MEASUREMENTS WITH THE M540 PATIENT MONITOR ON A CRITICALLY ILL INFANT. INITIALLY, NIBP MEASUREMENTS WERE SUCCESSFUL DURING TREATMENT IN THE RESUSCITATION UNIT AND ON THE WARD. APPROXIMATELY 4 HOURS AFTER BIRTH (AROUND 4:00 P.M.), ONLY MEAN ARTERIAL PRESSURE (MAD) READINGS WERE POSSIBLE. AFTER AN ADDITIONAL 2 HOURS (AROUND 6:00 P.M.), NO MEASUREMENTS COULD BE OBTAINED. NORMAL NIBP MEASUREMENT RESUMED APPROXIMATELY 7 HOURS LATER (AROUND 1:00 A.M.) IN THIS CASE THERE WAS NO ADVERSE PATIENT IMPACT. HOWEVER, THE INABILITY TO OBTAIN THE DESIRED PARAMETER READING USING THE INFINITY ACUTE CARE SYSTEM ON A CRITICAL PATIENT HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THIS MALFUNCTION WERE TO RECUR.

  Patient problems: Insufficient Information

  MAUDE report 23818274 ↗
• MalfunctionDec 15, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT THE NIBP (NON-INVASIVE BLOOD PRESSURE) MEASUREMENT FEATURE ON THE IACS (INFINITY ACUTE CARE SYSTEM) M540 PATIENT MONITOR REMAINED NON-FUNCTIONAL FOR NEONATES WEIGHING LESS THAN 1000 GRAMS. ON (B)(6) 2025, 12:30 A NEONATE WEIGHING 780 GRAMS REQUIRED CONTINUOUS MONITORING. DUE TO THE INABILITY TO OBTAIN NIBP READINGS WITH THE IACS, A PHILIPS MONITOR WAS USED TO ENSURE CONTINUOUS MEASUREMENT. ON (B)(6), ONCE THE NEONATE¿S CONDITION STABILIZED AND VITAL SIGNS IMPROVED, NIBP MEASUREMENTS COULD AGAIN BE PERFORMED USING THE IACS. NO PATIENT HARM OCCURRED DURING THIS PERIOD; HOWEVER, THE INABILITY TO MEASURE NIBP IN EXTREMELY LOW-WEIGHT NEONATES PRESENTS A POTENTIAL RISK FOR DELAYED CLINICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803326 ↗
• MalfunctionNov 24, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED ON (B)(6) 2025, AT APPROXIMATELY 04:18 A.M., A VENTRICULAR TACHYCARDIA (VT) ALARM LASTING APPROXIMATELY NINE MINUTES WAS NOT DISPLAYED AT THE CENTRAL MONITORING STATION. THE PATIENT PARAMETERS, INCLUDING ELECTROCARDIOGRAM (ECG) VALUES, WERE TRANSMITTED AND DISPLAYED CORRECTLY AT THE CENTRAL STATION; HOWEVER, NO ALARM NOTIFICATION WAS GENERATED OR DISPLAYED DURING THE REPORTED TIMEFRAME. THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 23632746 ↗
• MalfunctionNov 3, 2025Low Readings; Low Readings

  IT WAS REPORTED THE NON-INVASIVE BLOOD PRESSURE (NIBP) CUFF WAS USED ON A PATIENT TO OBTAIN A NIBP READING. THE READING WAS LOW BUT WITHIN THE MINIMUM ACCEPTABLE RANGE, SO THE NURSE DECIDED NOT TO GIVE THE PATIENT FENTANYL BOLUSES FOR PAIN MANAGEMENT. THE FOLLOWING DAY, THE SAME CUFF WAS USED TO OBTAIN ANOTHER NIBP READING BUT THE READING WAS VERY LOW, WHICH PROMPTED THE USER TO INSPECT THE CUFF. DURING THEIR INSPECTION IT WAS FOUND THE CUFF HAD SMALL TEARS ALONG THE VELCRO. THE USER EXPRESSED CONCERNS THAT THESE TEARS COULD HAVE IMPACTED THE ACCURACY OF THE NIBP READING. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451392 ↗
• MalfunctionApr 3, 2025Disconnection; Communication or Transmission Problem; Intermittent Communication Failure; Disconnection; Communication or Transmission Problem; Intermittent Communication Failure

  IT WAS REPORTED THAT THE INFINITY M540 MONITOR DISCONNECTED FROM THE INFINITY MEDICAL COCKPIT C500 DURING A PATIENT CARDIAC PROCEDURE AND THE M540 MONITOR WAS SWAPPED OUT AS A RESULT. ALTHOUGH AN INTERRUPTION IN PATIENT MONITORING OCCURRED, NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762175 ↗
• MalfunctionApr 1, 2025Failure to Select Signal; Capturing Problem; Reset Problem; Failure to Select Signal; Capturing Problem; Reset Problem

  IT WAS REPORTED THAT NIBP INTERVAL WAS UNAVAILABLE AT THE LOCAL M540 MONITOR AND THE MONITOR WAS SWAPPED OUT. THERE WAS A DELAY IN PATIENT CARE BECAUSE OF THE REPORTED EVENT. A DELAY IN PATIENT CARE CAN RESULT IN ADVERSE PATIENT CONSEQUENCES. IN THIS CASE, THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741334 ↗
• MalfunctionMar 19, 2025No Device Output; Intermittent Communication Failure; No Device Output; Intermittent Communication Failure

  IT WAS REPORTED A DISCONNECTION BETWEEN THE COCKPIT AND M540 MONITOR DURING PATIENT USE RESULTED IN AN INTERRUPTION IN LIVE PATIENT MONITORING. THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646318 ↗
• MalfunctionMar 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ANESTHETIST USED ECG CABLES IN AUTO SETTING FOR 3 PATIENT CASES WITHOUT ISSUE, HOWEVER, DURING THE FOURTH CASE THE ECG DETECTION FAILED TO WORK PROPERLY. AS SHOWN IN THE PROVIDED VIDEO, THE ECG WAVEFORMS WERE NOT DISPLAYED, BUT THE NUMERIC VALUES OF THE ECG PARAMETERS WERE STILL AVAILABLE. THE CABLES WERE EXCHANGED AS AN ATTEMPT TO RESOLVE THE ISSUE, BUT THE ISSUE PERSISTED. THEY THEN DECIDED TO CHANGE THE AUTODETECTION TO 3 LEAD AND THE ECG WAVEFORMS RETURNED. A 10-MINUTE DELAY IN PATIENT CARE WAS REPORTED BUT THERE WAS NO ADVERSE PATIENT IMPACT AS A RESULT OF THIS DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621359 ↗
• MalfunctionMar 10, 2025Unable to Obtain Readings; Device Sensing Problem; Unable to Obtain Readings; Device Sensing Problem

  THE CUSTOMER REPORTED THAT THE INFINITY ACUTE CARE SYSTEM (IACS) M540 MONITOR WAS UNABLE TO OBTAIN A NON-INVASIVE BLOOD PRESSURE (NIBP) MEASUREMENT ON A CRITICAL PATIENT IN THE NICU THROUGHOUT THE DAY ON (B)(6) , TO (B)(6) 2025. THE CUSTOMER REPORTED THAT THEY WERE ABLE TO OBTAIN A NIBP MEASUREMENT ON A DELTA MONITOR, BUT THAT ADMINISTRATION OF INOTROPE MEDICATION HAD BEEN DELAYED FOR 15-20 MINUTES. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21561113 ↗
• MalfunctionFeb 19, 2025Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT AN INFINITY ACUTE CARE SYSTEM M540 MONITOR COULD NOT OBTAIN BLOOD PRESSURE MEASUREMENT ON A NEONATAL PATIENT. THE USERS HAD TO SWITCH DEVICES TO THEN OBTAIN A MEASUREMENT. THE ADMINISTRATION OF MEDICATION WAS DELAYED DUE TO THIS ISSUE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: Insufficient Information; Tachycardia

  MAUDE report 21415342 ↗
• MalfunctionFeb 19, 2025Failure to Sense; Low Readings; Failure to Sense; Low Readings

  CORRECTION: IT WAS REPORTED THAT THE INFINITY ACUTE CARE SYSTEM (IACS) M540 MONITOR DISPLAYED AN INACCURATE HR, AND THAT MEDICATION WAS DELAYED, AND THAT THE ADMINISTRATION OF MEDICATION WAS DELAYED.

  Patient problems: Insufficient Information; Tachycardia

  MAUDE report 21415315 ↗
• MalfunctionFeb 7, 2025Failure to Sense; Communication or Transmission Problem; Failure to Sense; Communication or Transmission Problem

  IT WAS REPORTED THAT A AN M540 MONITOR WAS SET TO AUTOMATICALLY RECORD BLOOD PRESSURE ON A PATIENT UNDER ANESTHESIA EVERY 2.5 MINUTES, BUT THE DEVICE FAILED TO DO SO WITHOUT AN ALARM OR NOTIFICATION. THIS PATIENTS' BLOOD PRESSURE WAS ALSO BEING MONITORED BY AN ARTERIAL LINE CONTINUOUSLY. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334847 ↗
• MalfunctionJan 23, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE C700 COCKPIT REBOOTED LOSING CONNECTION TO THE (ICS) INFINITY CENTRAL STATION. THE STAFF REPORTED IT TOOK ABOUT TWO MINUTES TO COME BACK ONLINE. THE M540 BEDSIDE MONITOR ALSO FROZE AND NEEDED TO BE RESTARTED. THE C700 SHUTDOWN AGAIN AFTER THE RESTART. THE STAFF PERFORMED A HARD SHUT DOWN AND RESTART, WHICH HAS RESOLVED THE ISSUE THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219563 ↗
• MalfunctionJan 7, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE M540 MONITOR IS SHUTTING DOWN DURING A CASE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE DEVICE WAS SWAPPED WITH ANOTHER M540 MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093733 ↗
• MalfunctionDec 18, 2024Disconnection; No Display/Image; Disconnection; No Display/Image

  IT WAS REPORTED THAT THE C500 COCKPIT CONTINUALLY DISCONNECTED FROM THE M540 AND SHOWED A BLANK SCREEN DURING TWO OPERATING PROCEDURES ON (B)(6) 2024. THE C500 COCKPIT SCREEN WOULD GO ENTIRELY BLACK FOR 5 SECONDS AT A TIME. AFTER THE 5 SECONDS OF A BLANK SCREEN, THE DISPLAY WOULD SHOW AN "M540 DISCONNECTED," MESSAGE, FOLLOWED BY THE MONITORED PARAMETERS EVENTUALLY RETURNING TO THE DISPLAY. HOWEVER, NOT ALL WAVEFORMS WERE VISIBLE WHEN THE PARAMETERS RETURNED. THE CUSTOMER CONFIRMED THE M540 WAS NOT AFFECTED BY THIS ERROR ON THE C500, AS IT CONTINUED TO MONITOR WITH ALL WAVEFORMS AND PARAMETERS VISIBLE ON THE M540 SCREEN. THIS INFINITY ACUTE CARE SYSTEM (IACS) WAS NOT MONITORED BY A CENTRALSTATION. THE M500 CHARGING PINS WERE CONFIRMED TO HAVE BEEN INTACT AND NOT DAMAGED. IT WAS NOTED THAT THE C500 WAS MOUNTED ON AN A500 PERSEUS. THE CLINICIAN ATTEMPTED TO RESOLVE THE ISSUE BY SWAPPING OUT THE M540 DEVICE, BUT THE PROBLEM CONTINUED TO OCCUR WITH EACH NEW M540. THE ENTIRE A500 PERSEUS DEVICE WAS TAKEN OUT OF CLINICAL USE.

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

  MAUDE report 20965129 ↗
• MalfunctionOct 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE M540 AT BED MHIA5 IN WARD 43 SUDDENLY LOST ITS PROFILE WHILE IN PATIENT USE. THE CUSTOMER SAW THAT THE ALARM SOUND WAS OFF FOR ECMO, AND THAT OTHER ALARMS WERE TURNED ON THAT WERE NOT WANTED BY THE USER. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT OR DEATH.

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

  MAUDE report 20466488 ↗
• MalfunctionOct 9, 2024No Device Output; Self-Activation or Keying; Failure to Read Input Signal; No Device Output; Self-Activation or Keying; Failure to Read Input Signal

  THE CUSTOMER REPORTED THAT THE M540 WENT INTO STANDBY MODE WHILE ON A PATIENT WITHOUT INTERACTION IN THE PRESENCE OF TWO USERS. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407893 ↗
• MalfunctionOct 9, 2024No Audible Prompt/Feedback; No Visual Prompts/Feedback; No Audible Prompt/Feedback; No Visual Prompts/Feedback

  THE MEDICAL TECHNICIAN REPORTED TO THE FSE THAT AN ERROR OCCURRED ON 09/27/2024. THE COMPLAINT REPORTS THAT THERE WERE MISSING CURVES ON THE STANDALONE IACS, AND THAT THE MALFUNCTION WOULD REOCCUR. IT WAS REPORTED THAT THE INFORMATION CAN'T BE SEEN ON THE CENTRAL, AND THERE IS NO ALARM HEARD OR SEEN. THERE IS REPORTEDLY NO ALARM OF THE DISCONNECTION. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407110 ↗
• MalfunctionOct 9, 2024No Display/Image; No Device Output; Inappropriate Audible Prompt/Feedback; Unexpected Shutdown; No Display/Image; No Device Output; Inappropriate Audible Prompt/Feedback; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT AN M540 WENT BLACK AND HAD A CONTINUOUS ALARM TONE ON (B)(6) 2024 AT 11:11 WHILE ON A PATIENT. THE DEVICE WAS IMMEDIATELY REMOVED FROM USER AND SWAPPED WITH ANOTHER WORKING MONITOR. NO DETAILS REGARDING THE PATIENT CONDITION OR TREATMENT WERE PROVIDED. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407096 ↗
• MalfunctionOct 3, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE INFINITY ACUTE CARE SYSTEM (IACS) M540 DID NOT DISPLAY THE CORRECT ELECTROCARDIOGRAM (ECG) TRACING. THE MONITOR DISPLAYED A TRACING THAT WAS LABELED "ASYSTOLE," BUT IT APPEARED LIKE A VENTRICULAR FIBRILLATION RHYTHM, BUT IT WAS NOT. THE CUSTOMER CHANGED OUT THE LEADS AND WIRES, BUT THE EVENT PERSISTED. THE M540 WAS THEN EXCHANGED, AND THE ISSUE RESOLVED. THERE WAS NO INTERRUPTION IN PATIENT CARE. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362509 ↗

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.