BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CARDIAC MONITOR

    MDR report key: 24298932 · Received February 9, 2026

    Report

    Report Number
    MW5183584
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 19, 2026
    Report Date
    January 19, 2026
    Manufacturer
    PHYSIO-CONTROL MAASTRICHT, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PARAMEDIC
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT WAS PLACED ON CARDIAC MONITOR WITH MONITOR NOT DISPLAYING RHYTHM ON SCREEN. CABLES THEN NEEDED TO BE DETACHED THEN RE-ATTACHED TO MONITOR. ONCE RHYTHM DISPLAYS, HEART RATE ON MONITOR DISPLAYS INCORRECTLY, VERIFIED BY MANUALLY FEELING FOR PULSE. AFTER APPROX 10-15 SECONDS, MONITOR CORRECTS ITSELF AND DISPLAYS CORRECT PULSE. MONITOR IS DELAYING PT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362259 LIFEPAK CARDIAC MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL MAASTRICHT, INC. 35

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other