IACS w/C700 MS25520Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04049098009799), received between Apr 25, 2022 and Mar 31, 2026 — classified as 1 death, 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (6 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• DeathMar 31, 2026No Audible Prompt/Feedback

  IT WAS REPORTED A PATIENT WAS FOUND UNCONSCIOUS ON THE FLOOR AND NOT CONNECTED TO THE INFINITY ACUTE CARE SYSTEM M540 PATIENT MONITOR. AT THE TIME THE PATIENT WAS DISCOVERED, NO ALARMS HAD BEEN TRIGGERED BY THE DEVICE. CLINICAL STAFF-INITIATED RESUSCITATION MEASURES IMMEDIATELY. DESPITE CONTINUED MEDICAL INTERVENTION, THE PATIENT WAS SUBSEQUENTLY PRONOUNCED DECEASED.

  Patient problems: Loss of consciousness

  MAUDE report 24742036 ↗
• MalfunctionMar 6, 2026No Audible Prompt/Feedback

  IT WAS REPORTED THAT THE INFINITY ACUTE CARE SYSTEM (M540) PATIENT MONITOR DID NOT ALARM FOR LOW SPO2. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24533702 ↗
• MalfunctionApr 10, 2025Smoking; Smoking

  IT WAS REPORTED THAT THE POWER SUPPLY, P2500, FOR THE INFINITY ACUTE CARE SYSTEM (IACS) SHOWED SIGNS OF SMOKE. THE NURSES IN THE ROOM STATED THE P2500 STARTED SMOKING SO THEY TRANSFERRED THE PATIENT TO ANOTHER ROOM. THE PATIENT WAS NOT CONNECTED TO THE DEVICE WHEN THE ISSUE OCCURRED. THERE WAS NO ADVERSE PATIENT IMPACT AND NO DELAY IN PATIENT CARE REPORTED. THE DEVICE WAS TAKEN OUT OF USE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21817774 ↗
• MalfunctionApr 1, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT THE INFINITY ACUTE CARE SYSTEM (IACS) STOPPED DISPLAYING ELECTROCARDIOGRAPHY (ECG) INFORMATION WHILE IT WAS CONNECTED TO A PRIMUS ANESTHESIA STATION. THE ECG INFORMATION STOPPED DISPLAYING AT BOTH THE M540 AND COCKPIT MONITORS. THE ISSUE RESULTED IN A 15-MINUTE DELAY IN PATIENT CARE, BUT NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739129 ↗
• MalfunctionMar 31, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE INFINITY CENTRAL STATION (ICS) AND INFINITY ACUTE CARE SYSTEM (IACS) INTERMITTENTLY DISPLAYED ST PARAMETERS AS. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21732120 ↗
• MalfunctionFeb 27, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT AFTER MOVING A PATIENT FROM INDUCTION TO UROLOGY, THE NIBP (NON--INVASIVE BLOOD PRESSURE) COULD NOT BE MEASURED WITH THE M540 MONITOR. THE PATIENT WAS CARDIOPULMONARY STABLE AND THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21480957 ↗
• MalfunctionOct 31, 2024Disconnection; Wireless Communication Problem; Disconnection; Wireless Communication Problem

  IT WAS REPORTED THAT THE M540 AND C700 DISCONNECTED AND THE M540 REBOOTED ON ITS OWN. THE REBOOT OF THE M540 OCCURRED DURING USE WITH A PATIENT BUT NO ADVERSE PATIENT IMPACT WAS REPORTED. THE DEVICE ALARMED APPROPRIATELY TO ALERT THE USER OF THE ISSUE.

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

  MAUDE report 20581907 ↗
• MalfunctionOct 4, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT AN M540 HAD ISSUES DISCONNECTING AT REGULAR INTERVALS. THE CUSTOMER DID NOT STATE IF THE M540 OR THE COCKPIT HAD THE FOLLOWING DEFECTS. THE CUSTOMER STATES THAT THE REPORTED DEVICE'S PARAMETERS WOULD ZERO FOR A SHORT TIME, AND THEN THE SCREEN WOULD TURN BLACK AND WARN THAT IT WAS DISCONNECTED FROM THE M540. THEN THE DEVICE WOULD THEN CONNECT ON ITS OWN. THE REPORTED DISCONNECTION WOULD OCCUR UP TO EVERY 4 MINUTES FOR 20-30 SECONDS, TAKING THE SAME AMOUNT OF TIME EACH TIME. THE MEDICAL TECHNICIAN ATTEMPTED TO RESTART ALL DEVICES AND REMOVE THE CABLES, WHICH DID NOT RESOLVE THE ISSUE. THE M540 WAS REPLACED SEVERAL TIMES. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371222 ↗
• MalfunctionOct 4, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE ST CHANGE IN VECTOR MAGNITUDE (STCVM) WAS VISIBLE AND TRENDS WERE REGISTERED AT THE INFINITY CENTRAL STATION (ICS) BETWEEN 16:30 AND 20:30 WHILE THE PATIENT WAS CONNECTED WITH 6 LEADS. THEN THE STCVM DISAPPEARED AT THE ICS AND ON THE INFINITY C500. THE STVCM CAME BACK MOMENTARILY WHEN THE 12 LEAD ELECTROCARDIOGRAM (ECG) WAS USED BUT DISAPPEARED AGAIN WHEN THE MONOLEAD WAS REMOVED. THE STCVM WAS ALSO NOT SEEN IN SYMPHONY DURING THESE TIMES. IT WAS NOTED THAT THE ECG WAS SEEN AT ALL TIMES WITH THE CORRECT LEADS. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20369085 ↗
• InjuryAug 7, 2024Unintended System Motion; No Audible Prompt/Feedback; Unintended System Motion; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE MONITOR KEPT GOING INTO STAND-BY MODE WHILE MONITORING THE PATIENT WHILE THE PATIENT WAS BEING PREPPER FOR ANESTHESIA. THE COMPLAINT FORM STATES THAT "THE PATIENT WAS ON THE TABLE AND HAD TO BE BAGGED", AND ALSO STATED NO REPORTED INJURY. NO PATIENT DEATH REPORTED.

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

  MAUDE report 19928529 ↗
• MalfunctionJun 28, 2024Inappropriate Audible Prompt/Feedback; Wireless Communication Problem; Inappropriate Audible Prompt/Feedback; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT ALARMS CANNOT BE ACKNOWLEDGED AT THE INFINITY CENTRAL STATION. IT WAS REPORTED THAT THE PATIENT DATA WAS MISSING, AND THAT THE VES DETECTION STOPPED WORKING. IT WAS NOTED THAT LEADS WERE SWITCHED TO THOSE WITH THE MOST CLEARLY DEVIATING QRS MORPHOLOGY TO SEE IF IT CAN DETECT AND IT REVERTS TO THE NORMAL DEFAULT SETTING AND TAKES 18 MIN BEFORE IT DETECTS VES AGAIN. THERE ARE MANY VES IN THE MEANTIME. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632789 ↗
• MalfunctionJun 28, 2024Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED THAT THE PATIENT MONITOR GOES OUT AND IT MARKED AS OFFLINE AT THE CENTRAL, AND THAT THE PATIENT DATA IS NO SAVED. THE CUSTOMER ALSO REPORTED THAT THE PATIENT INFORMATION APPEARED AT THE CENTRAL STATION 4 HOURS AFTER THE PATIENT WAS CONNECTED TO THE TELEMETRY UNIT AT 2 AM. THE STAFF STATED THAT THE PATIENT INFORMATION HAD NOT BEEN OBSERVED AT THE CENTRAL STATION UNTIL 6 AM. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632392 ↗
• MalfunctionJun 18, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THEY COULD ONLY SEE SHORT EVENTS IN REAL-TIME CURVES, AND THAT THERE IS NOTHING IN ICS EVENTS. IT WAS REPORTED THAT THIS MALFUNCTION OCCURRED ON (B)(6), AND THAT IF THERE IS A CVT OR AIVR, IT IS "SAVED DURING REAL-TIME CURVES" BUT IT DOES NOT ALARM OR SAVE. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE CUSTOMER ALLEGATION. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

  Patient problems: Idioventricular Rhythm; Thromboembolism

  MAUDE report 19558434 ↗
• MalfunctionMay 29, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THE M540 DISCONNECTED FROM THE COCKPIT DURING SURGERY, AND THAT THE REPLACED M540 RESET THE SYSTEM. THE CUSTOMER RETRIEVED A M540 FROM STORAGE, POWER IT ON, AND CONNECT THE PT TO THE MONITOR. THE CUSTOMER CONFIRMED THAT THERE WAS A 5-10 MINUTE DELAY IN PATIENT CARE WITH NO PATIENT INJURY OR ADVERSE IMPACT. NO PATIENT DEATH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19414869 ↗
• MalfunctionMay 29, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT THE M540 DISCONNECTED FROM THE COCKPIT DURING A BILATERAL KNEE SURGERY. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY, AND NO INTERRUPTION TO PATIENT MONITORING. THE CUSTOMER REPLACED THE M540 WITH ANOTHER M540. THERE WAS NO INJURY OR DEATH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19414394 ↗
• 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 18889192 ↗
• MalfunctionFeb 15, 2024Loose or Intermittent Connection; Unexpected Shutdown; Loose or Intermittent Connection; Unexpected Shutdown

  THE CUSTOMER REPORTED THE DRAEGER M540 REBOOTED. IT WAS ORIGINALLY REPORTED AS A DISCONNECT, BUT ONCE ON SITE, IT WAS ACTUALLY A M540 REBOOT AND CAME BACK ON. THERE WAS NO REPORT OF AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712662 ↗
• MalfunctionFeb 14, 2024No Device Output; No Visual Prompts/Feedback; No Device Output; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED THAT THE OR DEPARTMENT TO INFORM US THAT A SECOND M540 IS FAILING TO DISPLAY ECG INFORMATION ON THE IACS. THE CABLES WERE CHANGED WITHOUT ANY LUCK. THE FIRST UNIT WAS SWAPPED THE PREVIOUS UNIT WAITING FOR THE UNIT TO BE REPAIRED. THERE WAS NO REPORT OF AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703129 ↗
• MalfunctionFeb 12, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER STATES THAT THERE WAS NO EKG TRACING ON EITHER THE M540 OR THE C700. THE B/P AND O2 SAT READINGS WERE STILL DISPLAYED. THE CUSTOMER TRIED TURNING THE UNITS ON AND OFF AS WELL AS A NEW EKG CABLE AND EKG LEADS. NEITHER CORRECTED THE ISSUE. THE M540 WAS REPLACED WITH A DIFFERENT M540 AND THEN EKG TRACING WAS AVAILABLE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685162 ↗
• MalfunctionDec 15, 2023Failure to Analyze Signal; Failure to Analyze Signal

  IT WAS REPORTED THAT THE USERS OBSERVED SIGNAL ARTEFACTS ON THE ARTERIAL BLOOD PRESSURE CURVE DURING A SURGERY. THE ISSUE WAS INTERMITTENT AND, IT WAS REPORTED THAT ELECTROSURGICAL EQUIPMENT WAS IN USE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333534 ↗
• MalfunctionNov 13, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BEDSIDE MONITOR PERFORMS SPORADIC REBOOTS AND DOES NOT CONNECT ITSELF TO THE COCKPIT AGAIN AFTERWARDS, VISUALIZATION OF VITAL PARAMETER IS THUS IMPAIRED. THE ISSUE OCCURS WHEN HF SURGERY EQUIPMENT IS BEING USED BUT NOT EACH TIME. FOR REMEDY, A NEW BEDSIDE MONITOR MUST BE INTRODUCED. NO PATIENT CONSEQUENCES HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118941 ↗
• MalfunctionNov 8, 2023Erratic or Intermittent Display; Intermittent Communication Failure; Erratic or Intermittent Display; Intermittent Communication Failure

  IT WAS REPORTED THAT THE COCKPIT OF THE PATIENT MONITORING SYSTEM PERFORMED A REBOOT DURING USE. THE BEDPLACE MONITOR CONTINUED TO MONITOR THE PATIENT. NO PATIENT CONSEQUENCES WERE RESULTING FORM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090476 ↗
• MalfunctionNov 8, 2023Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE COCKPIT OF THE PATIENT MONITORING SYSTEM PERFORMED A REBOOT DURING USE. THE BEDPLACE MONITOR CONTINUED TO MONITOR THE PATIENT. NO PATIENT CONSEQUENCES WERE RESULTING FORM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090474 ↗
• MalfunctionSep 28, 2023Application Program Problem; Application Program Problem

  SEE INITIAL MFR. REPORT #.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832077 ↗
• MalfunctionApr 26, 2023No Audible Prompt/Feedback; Application Program Problem; No Audible Prompt/Feedback; Application Program Problem

  IT WAS REPORTED THAT THE SPO2 ALARM (ON OR OFF) IS NOT STORED IN THE IACS COCKPIT PROFILE. THE SPO2 ALARM IS ACTIVATED (ON) AND SAVED IN THE PROFILE. WHEN THE PATIENT IS ADMITTED AFTER DISCHARGE (CALLING UP THE DEFAULT PROFILE), THE SPO2 ALARM IS DEACTIVATED AGAIN (OFF). ONLY WHEN THE PROFILE IS ALSO SAVED IN THE M540 IS THE SPO2 ALARM AUTOMATICALLY ACTIVATED (ON) WHEN MONITORING IS STARTED. THE INSTRUCTIONS FOR USE GIVES NO INDICATION OF THIS. ASSESSMENT OF THE SITUATION: POTENTIAL DANGER TO THE PATIENT, AS THE SPO2 ALARM MAY BE INADVERTENTLY DEACTIVATED. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR. INVOLVED INFINITY M540, MS20401, SERIAL NUMBER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820441 ↗

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.