BEUDAMED
    FDA Adverse Event Death Summary report: N

    862451

    MDR report key: 24399741 · Received February 20, 2026

    Report

    Report Number
    1218950-2026-100078
    Event Type
    Death
    Date Received
    February 20, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 15, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DSI
    UDI-DI
    00884838093041
    PMA / PMN Number
    K151681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SUBMITTED REFERENCING THE PATIENT INFORMATION CENTER IX, BUT FURTHER INVESTIGATION DETERMINED THAT THE REPORTED DEVICE SHOULD HAVE BEEN THE INTELLIVUE MP70. THE FINAL REPORT HAS BEEN UPDATED APPROPRIATELY. THE PHILIPS TECHNICAL CONSULTANT (TC) WAS ADVISED THAT ON (B)(6) 2026, THE ECG LEADS WERE OFF THE PATIENT AND ECG LEADS OFF INOP ALARMS WERE IGNORED. THE PATIENT WAS FOUND UNRESPONSIVE WITH LEADS OFF AND CHEST TUBE REMOVED. AFTER PERFORMING A DEMONSTRATION OF LEADS OFF, AND AFTERWARD VIEWING THE CLINICAL AUDIT TRAIL, THE CUSTOMER STILL SEES BLUE INOP ALARMS ACCOMPANIED BY YELLOW INOPS. THE BED LABEL C02-01 WAS PROVIDED BUT A TIME FRAME WAS NOT. THE CUSTOMER REQUESTS TO UNDERSTAND WHY THEY WERE STILL SEEING BLUE INOPS ACCOMPANYING THE YELLOW INOPS. THE CUSTOMER IS ASKING, IF LEADS OFF WILL ALWAYS CREATE A YELLOW INOP? THE TC ADVISED THE CUSTOMER ON THE ORDER OF EVENTS. THE YELLOW ALARM IS SPECIFICALLY FOR ALL LEADS OFF. WHEN A LEAD IS REMOVED FROM THE PATIENT, THE SPECIFIC LEAD IS ANNOUNCED AS A BLUE INOP IMMEDIATELY FOLLOWED BY AN "ECG LEADS OFF" INOP WHILE THE MONITOR IS SEARCHING FOR A FALLBACK LEAD. IF A FALLBACK LEAD IS FOUND, THE ECG LEADS OFF ALARM SUBSIDES AND A BLUE INOP OCCURS ANNOUNCING THE SPECIFIC LEAD. SINCE ALL LEADS ARE NOT OFF OF THE PATIENT, THE YELLOW ALARM AND BANNER END. THE PROVIDED INFORMATION WAS REVIEWED BY A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS). THE CPS CONFIRMS THE INVESTIGATION AND INFORMATION PROVIDED TO THE CUSTOMER BY THE PHILIPS TC. INFORMATION FROM THE INFORMATION FOR USE (IFU) (MP20-90 INTELLIVUE PATIENT MONITOR REL. M.04 INSTRUCTIONS FOR USE (B)(4) (ENG) PG.83) STATES: INOPS ARE TECHNICAL ALARMS, THEY INDICATE THAT THE MONITOR CANNOT MEASURE OR DETECT ALARM CONDITIONS RELIABLY. IF AN INOP INTERRUPTS MONITORING AND ALARM DETECTION (FOR EXAMPLE, LEADS OFF), THE MONITOR PLACES A QUESTION MARK IN PLACE OF THE MEASUREMENT NUMERIC AND AN AUDIBLE INDICATOR TONE WILL BE SOUNDED. INOPS WITHOUT THIS AUDIBLE INDICATOR INDICATE THAT THERE MAY BE A PROBLEM WITH THE RELIABILITY OF THE DATA, BUT THAT MONITORING IS NOT INTERRUPTED. MOST INOPS ARE LIGHT BLUE, HOWEVER THERE ARE A SMALL NUMBER OF INOPS WHICH ARE ALWAYS YELLOW OR RED TO INDICATE A SEVERITY CORRESPONDING TO RED AND YELLOW ALARMS. WHEN THE INOP MESSAGE IS A SPECIFIC, SINGLE LEAD OFF (EX. V LEAD OFF, RA LEAD OFF, RESP LEAD OFF) THE ALARM BANNER IS CYAN WITHOUT ANY EXCLAMATION POINTS. ECG MONITORING AND ALARMING IS POSSIBLE WITH THE LEAD THAT REMAINS. ONCE ECG MONITORING IS NO LONGER POSSIBLE, THE ALARM MESSAGE CHANGES TO ECG LEADS OFF AND, IF CONFIGURED TO YELLOW OR RED, THE SELECTED SEVERITY IS SHOWN WITH TWO EXCLAMATION POINTS (YELLOW) OR THREE EXCLAMATION POINTS (RED). FOR THIS BED, C02-01 THE CPS IDENTIFIED, TWO ECG LEADS OFF ALARM MESSAGES IN THE AUDIT LOG ON (B)(6) 2026 AND THEY ARE BOTH CYAN. FROM THE PROVIDED DATA, THE OTHER ALARMS AROUND THE ECG LEADS OFF ARE ALSO AVAILABLE: ECG LEADS OFF AT 14:49:35 LASTED FOR ABOUT 11 SECONDS. THE SECOND INSTANCE OF ECG LEADS OFF AT 23:57:56 LASTED FOR >10 MINUTES. THE ECG LEADS OFF ALARM WAS ACKNOWLEDGED AT 23:59:24 FROM PIC IX MDR-ICU-CSV. BASED ON THE RESULTS OF THE ANALYSIS, THE PRODUCT IS WORKING AS DESIGNED, OPERATED AND CONFIGURED. PER THE INVESTIGATION NOTES, THE CONFIGURATION FOR ECG LEADS OFF WAS SUBSEQUENTLY CHANGED TO YELLOW AND ON-SITE PERSONNEL INDICATED THAT THE EQUIPMENT CONFIGURATION REFLECTED THE YELLOW SEVERITY CONFIGURATION. THE CUSTOMER WAS PROVIDED AN EXPLANATION ON THE ORDER OF EVENTS AND WAS SATISFIED WITH THE EXPLANATION PROVIDED. D4 UNIQUE DEVICE IDENTIFIER (UDI): THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO (B)(6) 2016 SO NO UDI REQUIRED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ECG LEADS OFF TECHNICAL INOP ALARM WAS IGNORED BY STAFF. THE ECG LEADS WERE OFF THE PATIENT, LEADING TO AN ECG LEADS OFF INOP ALARM, BUT THE ALARM WAS IGNORED. THE PATIENT WAS FOUND UNRESPONSIVE WITH ECG LEADS OFF AND CHEST TUBE REMOVED AND PRONOUNCED DECEASED. THE HOSPITAL IMPLEMENTED THE LEADS OFF INOP AS A YELLOW ALARM BUT QUESTIONS THEIR CLINICAL AUDIT LOG WHICH DISPLAYED BLUE INOPS ALONG WITH YELLOW INOP ALARMS. THE CUSTOMER REQUESTED ASSISTANCE WITH CONFIGURATION AND EDUCATION ON ALARM BEHAVIOR, SPECIFICALLY WHETHER LEADS OFF ALARMS CONDITIONS WILL ALWAYS BE ACCOMPANIED BY A YELLOW ESCALATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463634 862451 INTELLIVUE MP70 DSI PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death