BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 8764893 · Received July 5, 2019

    Report

    Report Number
    1218950-2019-04861
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Report Date
    June 13, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Removal / Correction Number
    FCO86100188A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE AC MODULE (API1AD41-000 C0419 C 002805) FOR THE DEVICE WOULD INTERMITTENTLY LOSE CONNECTIVITY AND THE AC LED LIGHT WOULD SUBSEQUENTLY TURN OFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE PATIENT/USER IMPACT AS A RESULT OF THE ALLEGED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559332 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1