IACS w/C500 MS25510Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04049098054409), received between Dec 30, 2021 and Sep 17, 2026 — classified as 2 deaths, 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 17, 2026No Audible Prompt/Feedback

  It was reported that, on the Infinity Central Station, a patient's systolic arterial pressure (ART) value of 70 mmHg was displayed while the low alarm threshold was configured at 75 mmHg. Despite the displayed value being below the configured alarm limit, no alarm was generated by the central station. No adverse patient effects, injury, or deterioration in clinical condition were reported. The device remained in clinical use. Subsequent on-site evaluation by Dräger confirmed that the alarm function was operational during testing. The cause of the reported alarm behavior is under investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802993 ↗
• MalfunctionJul 24, 2025No Device Output; No Device Output

  A DIABETIC PATIENT WAS ADMITTED WITH HYPERGLYCEMIA AND TAKEN TO THE OPERATING ROOM FOR A RIGHT FOOT WOUND DEBRIDEMENT. THE PROCEDURE WAS COMPLETED, BUT UPON REVERSAL OF ANESTHESIA, THE PATIENT DID NOT RESPOND. RESUSCITATION EFFORTS WERE PERFORMED BUT WERE UNSUCCESSFUL, AND THE PATIENT PASSED AWAY. THE CUSTOMER REPORTED THAT THE HR (HEART RATE) WAVEFORM WAS VISIBLE ON THE M540 PATIENT MONITOR, BUT NO HR VALUES WERE DISPLAYED. ADDITIONALLY, HR VALUES WERE DASHED OUT ON THE PRINTOUTS. FOLLOW-UP INSPECTION (JULY 11, 2025): A SITE VISIT WAS CONDUCTED FOR INSPECTION AND ERROR ANALYSIS. DURING THE VISIT, THE MONITOR FILTER SETTING WAS CORRECTED FOR USE IN AN ELECTRICAL SURGICAL ENVIRONMENT FROM 'MONITOR' TO 'ESU'(ELECTRICAL SURGICAL UNIT), RESOLVING THE ISSUE WITH MISSING HR VALUES. HR VALUES APPEARED ON THE MONITOR AND WERE CORRECTLY PRINTED. THE PATIENT MONITOR WAS TESTED ON-SITE WITH THE CUSTOMER AND SUCCESSFULLY READ NIBP AND SPO2 DATA THROUGHOUT THE TEST. THE DATA WAS PRINTED CORRECTLY, CONFIRMING NORMAL DEVICE FUNCTIONALITY.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592384 ↗
• MalfunctionJul 9, 2025Communication or Transmission Problem; Connection Problem; Intermittent Communication Failure; Communication or Transmission Problem; Connection Problem; Intermittent Communication Failure

  IT WAS REPORTED THAT THE INFINITY M540 PATIENT MONITOR LOST COMMUNICATION WITH THE DUAL HEMO M-CABLE AND THE ASSOCIATED INVASIVE PRESSURE TRANSDUCERS DURING A SURGICAL PROCEDURE WITH A PATIENT. IT WAS NOTED THAT THE CUSTOMER ATTEMPTED TO SWAP OUT THE CABLES, BUT THIS DID NOT RESOLVE THE REPORTED PROBLEM. EVENTUALLY, THE INFINITY M540 PATIENT MONITOR WAS SWAPPED OUT TO RESOLVE THE ISSUE. THERE WAS NO INTERRUPTION IN PATIENT CARE OR ADVERSE PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460871 ↗
• MalfunctionMar 12, 2025Device Sensing Problem; Activation Failure; Device Sensing Problem; Activation Failure

  IT WAS REPORTED THAT SEVERAL TIMES THAT THE AUTOMATIC NIBP (NON-INVASIVE BLOOD PRESSURE) MEASUREMENT ON THE M540 MONITOR DOES NOT START. THE "AUTO" FIELD INCLUDING THE PROGRESS BAR HAS SUDDENLY DISAPPEARED. FOUR TO FIVE INTERVAL MEASUREMENTS WORK AND THEN NOTHING MORE. THIS ISSUE WAS RESOLVED BY PUTTING THE COCKPIT INTO STANDBY AND RE-ENABLING IT. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582976 ↗
• MalfunctionFeb 21, 2025No Display/Image; Connection Problem; Intermittent Communication Failure; No Display/Image; Connection Problem; Intermittent Communication Failure

  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 CENTRAL STATION. 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. NOTE THAT THIS MDR IS TO CAPTURE SECOND EVENT THAT OCCURRED AS ITS STATED THAT THE ISSUE OCCURRED DURING TWO OPERATING PROCEDURES. IT WAS CONFIRMED (B)(6) 2025, TH

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

  MAUDE report 21437832 ↗
• MalfunctionDec 17, 2024Loss of Data; Loss of Data

  IT WAS REPORTED THAT THE C500 COCKPIT IN THE CRITICAL CARE UNIT WARD WAS AUTO-DISCHARGING PATIENTS AND LOSING FULL DISCLOSURE DATA FROM THE CENTRAL STATION. IN THIS CASE THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20952742 ↗
• MalfunctionSep 9, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE IACS C500 AND M540 SCREEN FROZE AND WENT BLACK, THEN RESTART OCCURRED. AFTER THAT, THERE IS NO REPRODUCIBILITY OF RESTART. HOWEVER, THE RECORDER COULD NOT BE USED, AND NO OUTPUT WAS POSSIBLE EVEN BEFORE THE RESTART OCCURRED. ALSO, SOMETIMES NOISE OCCURRED EVEN BEFORE THE RESTART OCCURRED. THE AFFECTED C500 IS DRAEGER REPAIR SUBSTITUTE DEVICE. IT WAS REPLACED WITH ANOTHER REPAIR SUBSTITUTE DEVICE. IT SEEMS M540 ALSO RESTARTED AT THE SAME TIME OR WITH A SHORT TIME LAG.

  Patient problems: Insufficient Information

  MAUDE report 20174048 ↗
• MalfunctionAug 1, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT THERE WAS A "DROPOUT" BETWEEN THE M540 AND C500 "EVERY FEW SECONDS" ON (B)(6) 2024 AT 12:30. THE CUSTOMER RECONNECTED THE M540 TO ANOTHER M500 WHICH DID NOT RESOLVE THE ISSUE, AND THEN ATTEMPTED WITH A NEW M540 WHICH ALSO HAD THE SAME ISSUE. THEN THE CUSTOMER PLACED THE ORIGINAL M540 ON THE ORIGINAL M500, AND THE FAULT HAD CLEARED WITH NO REOCCURRENCE SINCE. NO ADVERSE PATIENT IMPACT OR DEATH REPORTED.

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

  MAUDE report 19885652 ↗
• MalfunctionApr 25, 2024Insufficient Device Problem Information; Unexpected Shutdown; Insufficient Device Problem Information; Unexpected Shutdown

  IT WAS REPORTED BY THE CUSTOMER THAT ON APRIL 1ST AROUND 9:45AM THAT THE IACS REBOOTED TWICE DURING ELECTROSURGERY, AND THAT IT WAS "NOT CLEAR IF THE M540 CONTINUED TO MONITOR THE PATIENT". NO PATIENT INJURY OR DEATH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184909 ↗
• MalfunctionApr 3, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT AN M540 DISCONNECTED FROM THE C700 DURING A VASCULAR OPERATION. THE ISSUE WAS ONLY RESOLVED BY THE CUSTOMER MANUALLY REBOOTING THE M540 AND C700, AND THE DEVICES WERE SWAPPED OUT WITH DELTA MONITORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031502 ↗
• MalfunctionApr 2, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT AN M540 DISCONNECTED FROM THE C700 DURING A VASCULAR OPERATION. THE ISSUE WAS ONLY RESOLVED BY THE CUSTOMER MANUALLY REBOOTING THE M540 AND C700, AND THE DEVICES WERE SWAPPED OUT WITH DELTA MONITORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19025949 ↗
• MalfunctionMar 26, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT DURING A JOINT REPLACEMENT SURGERY, THREE M540S WERE UNABLE TO CONNECT TO THE COCKPIT. THE FIRST M540 DISCONNECTED WHILE AN ESU WAS IN USE, AND TWO SPARES WERE USED BEFORE THE THIRD SPARE M540 SUCCESSFULLY CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977416 ↗
• MalfunctionMar 25, 2024Disconnection; Connection Problem; Intermittent Communication Failure; Disconnection; Connection Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT DURING A JOINT REPLACEMENT SURGERY, THREE M540S WERE UNABLE TO CONNECT TO THE COCKPIT. THE FIRST M540 DISCONNECTED WHILE AN ESU WAS IN USE, AND TWO SPARES WERE USED BEFORE THE THIRD SPARE M540 SUCCESSFULLY CONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18974095 ↗
• InjuryFeb 29, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THREE INTENSIVE CARE NURSES WERE WORKING ON A PATIENT IN A 3-BED PATIENT ROOM WHEN ANOTHER PATIENT'S SPO2 DROPPED TO 17%. THE LOW VALUE WAS NOTICED BY A DOCTOR WHO HAD JUST ENTERED THE ROOM, AND THE PATIENT WAS STABILIZED USING AN AMBU BAG. A NURSE WITNESS THAT THE ALARM MUTE OR ALARM PAUSE HAD BEEN ACTIVATED BEFORE SHE CARED FOR THE PATIENT, EVEN THOUGH NO STAFF HAD REPORTEDLY HIT THE BUTTON. FOLLOW UP INFORMATION HAS BEEN REQUESTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18812461 ↗
• InjuryFeb 21, 2024No Device Output; No Audible Prompt/Feedback; No Device Output; No Audible Prompt/Feedback

  IT WAS REPORTED THAT NO ALARM ARRIVED AT THE ICS AT AN SPO2 SATURATION OF 42%. THE M540 NOR THE C500 ALARMED THE LOW SPO2, AND USERS REPORTED NOT TURNING OFF THE ALARMS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18747596 ↗
• MalfunctionFeb 12, 2024Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED DURING A CASE THE M540 NIBP WAS LEAKING. THERE WAS NO INJURY REPORTED. ADDITIONALLY, THERE WAS NO INTERRUPTION IN PATIENT CARE AS THE UNIT WAS IMMEDIATELY SWAPPED OUT FOR ANOTHER M540.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686755 ↗
• MalfunctionFeb 9, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT ON (B)(6) 2024 AT APPROXIMATELY 9AM, THE DRAEGER M540 WILL NOT STAY CONNECTED TO THE C700 COCKPIT. IT WAS NOTICED THAT THERE WAS COMMUNICATION LOST TO C700 FROM M540, AND THE M540 WAS REPLACED WITH A BACKUP UNIT AND THE CASE CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO ADVERSE EVENT OR PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677304 ↗
• MalfunctionJan 22, 2024Inaudible or Unclear Audible Prompt/Feedback; Inaudible or Unclear Audible Prompt/Feedback

  IT WAS REPORTED THAT THE PATIENT HAD DESATURATIONS DOWN TO 5% AND BRADYCARDIA DOWN TO 23%. THE NURSE WAS NEAR THE BABY¿S COT SIDE AND WRITING HER NOTES AND SHE COULD NOT HEAR THE ALARM. FATHER OF ANOTHER BABY ALERTED NURSE TO CHECK THE BABY WHEN HE SAW BOTH RED LIGHTS FLASHING ON THE MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552580 ↗
• MalfunctionJan 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE M540 HAS LOST ITS CONFIGURATION AND HAS VERY POOR DETECTION OF THE ECG SIGNAL ASYSTOLE ALARM, ALTHOUGH A WEAK CURVE IS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503360 ↗
• InjuryDec 1, 2023No Display/Image; No Display/Image

  IT WAS REPORTED TO DRÄGER THAT THE COCKPIT OF THE PATIENT MONITORING SYSTEM SPORADICALLY LOSES THE SCREEN IMAGE. AS PER REPORT, A SURGERY HAD TO BE ABORTED IN CONSEQUENCE OF THAT. NO CONSEQUENCES TO THE PATIENT'S HEALTH HAVE RESULTED FROM THE EVENT, FINALLY. REMARK: BASED ON THE INITIAL REPORT RECEIVED ON NOV. 15TH, THE CASE WAS ASSESSED AS BEING REPORTABLE BECAUSE A SERIOUS INJURY CANNOT BE EXCLUDED IN CASE OF RECURRENCE. ON NOV. 22ND DRÄGER HOWEVER RECEIVED THE ADDITIONAL INFORMATION THAT THE INITIAL SURGERY WAS ABORTED DUE TO THE MONITOR'S MALFUNCTION. CONSEQUENTLY, THE CASE UNDERWENT A RE-ASSESSMENT AND WAS CONSIDERED TO MEET THE DEFINITION OF SERIOUS INJURY DUE TO THE PROLONGED SURGERY TIME/HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244236 ↗
• DeathNov 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT DIED AND, A REVIEW AND ANALYSIS OF PATIENT TREND DATA AND ALARM HISTORY WAS REQUESTED. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION BUT SINCE THE INVESTIGATION HAS JUST STARTED; AT THIS TIME, WE CANNOT RULE OUT THAT THE DRÄGER MEDICAL DEVICE MENTIONED WAS A FACTOR IN THE PATIENT¿S DEATH.

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

  MAUDE report 18046193 ↗
• MalfunctionJul 7, 2023Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT DURING USE, THE INFINITY ACUTE CARE SYSTEM (IACS) OFTEN EXPERIENCES INTERFERENCE. ALTHOUGH THE OPERATING ROOM MODE HAS BEEN TURNED ON AND THE AMPLITUDE HAS BEEN ADJUSTED, THERE IS STILL A SIGNIFICANT AMOUNT OF INTERFERENCE. ADDITIONALLY, ECG OFTEN GENERATES ERRONEOUS SIGNALS, INCLUDING WHEN THE HEART STOPS BEATING DURING HEART SURGERY, THE MONITOR STILL HAS A SINE WAVE WAVEFORM, AND AFTER THE HEART RESTARTS, THE MONITOR NEEDS TO WAIT FOR A LONG TIME TO RECOVER. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR.

  Patient problems: Asystole

  MAUDE report 17277767 ↗
• MalfunctionApr 5, 2023Smoking; Smoking

  IT WAS REPORTED THERE WAS A BURNING SMELL COMING FROM THE P2500 [POWER SUPPLY] DURING USE IN A PATIENT CARE ENVIRONMENT. IT WAS NOTED BY THE HOSPITAL BIOMED THAT THE ODOR WAS THAT OF A BURNT OUT ELECTROLYTIC CAPACITOR. THE WORK ORDER COMPLETED BY THE CLINICAL STAFF MEMBER STATED ¿HEAVY SMELL OF BURNING WIRES, SPARKING - URGENT - SHUTTING DOWN ENTIRE FLOOR, TAKING PATIENTS OUT¿. THIS WAS CLARIFIED AS 3 PATIENTS WERE REMOVED FROM THE UNIT. WHEN THE BIOMED ARRIVED THERE WAS NO FIRE OR SMOKE SEEN. THE CITED POWER SUPPLY WAS REPLACED. NO PATIENT OR STAFF INJURY OCCURRED. THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR. THE INFINITY P2500 IS THE DEDICATED POWER SOURCE AND NETWORKING HUB FOR THE INFINITY M540 PATIENT MONITOR AND INFINITY MEDICAL COCKPIT. THE P2500 IN THIS CASE IS PART NUMBER MS22277 / SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686670 ↗
• MalfunctionOct 3, 2022Flare or Flash; Flare or Flash

  IT WAS REPORTED THAT THE INFINITY P2500 POWER SUPPLY CAUSED A SHORT CIRCUIT, AS A RESULT OF WHICH THE POWER BRIEFLY FAILED IN THE AFFECTED ROOM, SPARKS AND SMALL AMOUNTS OF SMOKE WERE NOTED. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE POWER SUPPLY WAS IMMEDIATELY TAKEN OUT OF SERVICE, DISMANTLED FOR FURTHER INVESTIGATION AND SECURED SO THAT THE DEVICE CAN BE SENT IN FOR CLOSER EXAMINATION. A NEW POWER SUPPLY UNIT HAS ALREADY BEEN INSTALLED AT THE CUSTOMER'S SITE. THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR. THE INFINITY P2500 POWER SUPPLY (MS22277, SERIAL # (B)(6)) IS THE DEDICATED POWER SOURCE AND NETWORKING HUB FOR THE INFINITY M540 PATIENT MONITOR AND INFINITY MEDICAL COCKPIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530101 ↗
• DeathDec 30, 2021No Audible Prompt/Feedback; Wireless Communication Problem; No Audible Prompt/Feedback; Wireless Communication Problem

  IT WAS REPORTED THAT: PATIENT WAS CONNECTED TO M540 AND NETWORK TO CENTRAL STATION (HARDWIRED) AND ON CONTINUOUS ECG MONITORING. LAST ALARM CAPTURED ON CENTRAL STATION WAS SPO2 <88 AT 01:08H (AFTER ARRESTED) AND AIVR AT 23:30H (BEFORE ARRESTED). PATIENT HR DROPPED TO <45 AT 00:20H, WENT TO BRADYCARDIA AT 00:41H AND ASYSTOLE AT 00:42H. ALL ALARMED AT BEDSIDE MONITOR, ASYSTOLE EVENTS CAPTURED IN TRENDS DATA AND TRENDS GRAPH. EVENTS NOT CAPTURED UNDER EVENTS AND NO FULL DISCLOSURE RECORD AFTER 00:03H. SUMMARY: M540 DEVICE ALARMED AS NORMAL BEHAVIOR. SITE FEEDBACK IS ICS DID NOT ALARM FOR BRADYCARDIA AND ASYSTOLE. PATIENT CODED AND GIVEN RESUSCITATION, TRANSFERRED TO CVICU. UNFORTUNATELY PATIENT DIED. ****************************** IN THIS CASE, THE INFINITY ACUTE CARE SYSTEM (IACS) WHICH INCLUDES THE M540 PATIENT MONITOR WAS BEING USED WITH AN INFINITY CENTRAL STATION (ICS). ICS S# (B)(6) ICS MODEL MS32504. ICS SOFTWARE VERSION VG2.1.1.

  Patient problems: Asystole; Bradycardia; Cardiac Arrest; Respiratory Arrest

  MAUDE report 13119092 ↗

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.