BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 6376994 · Received March 3, 2017

    Report

    Report Number
    1218950-2017-01499
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Report Date
    February 13, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE TAKES TOO LONG TO CHARGE AND THE ENERGY OUTPUT IS OUT OF SPEC. THE CUSTOMER STATED THE ENERGY OUTPUT MEASURED BY HIS ANALYZER WHILE PERFORMING THE DEFIB TEST AT 200 J IS AROUND 166 J. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158307 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1