BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 6198488 · Received December 22, 2016

    Report

    Report Number
    1218950-2016-08092
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Report Date
    November 30, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE CAN'T MEASURE ECG. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849154 HEARTSTART XL+ DEFIBRILLATOR/MONITOR ALS DEFIBRILLATOR MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1