BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 7846400 · Received September 5, 2018

    Report

    Report Number
    1218950-2018-07125
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Report Date
    August 12, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SOFTWARE ISSUE. CLARIFICATION WAS PROVIDED THAT THE THERAPY SWITCH WAS GIVING INACCURATE SELECTION; WHEN 30 J IS SELECTED, IT RECOGNIZES 10 J. THUS THE SYSTEM OPTS OUT TO SERVICE MODE EVERY TIME THE USER TRIES TO PERFORM THE OPERATIONAL CHECK BECAUSE IT IS SENSING THE WRONG SELECTION. THERE WAS NO REPORTED PATIENT OR USER INVOLVEMENT AND NO ADVERSE PATIENT/USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687798 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1