BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRS - EMS DEFIBRILLATOR

    MDR report key: 3770294 · Received March 7, 2014

    Report

    Report Number
    1218950-2014-01260
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    February 5, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE DEVICE, THE PHILIPS BENCH ENGINEER NOTED THE BATTERY PINS WERE LOOSE. THERE WAS NO REPORT OF NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139753 HEARTSTART MRS - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1