BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2935503 · Received January 4, 2013

    Report

    Report Number
    1218950-2013-00041
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PATIENT INVOLVEMENT. A PHILIPS BENCH TECHNICIAN EVALUATED THE DEVICE. THE BATTERY PCA WAS FOUND TO FAIL VISUAL INSPECTION WHERE THE PINS WERE LOOSE ON SLOT A. THE ERROR LOG CONTAINED MULTIPLE POWER LOSS EVENTS THAT SUPPORT THE CUSTOMER'S CLAIM OF POWER LOSS. THE DEVICE WAS TESTED BUT THE SHUT DOWN PROBLEM WAS NOT RECREATED. NOTE THAT THE CUSTOMER DID NOT RETURN THE INVOLVED BATTERIES FOR EVALUATION. AS OF (B)(4) 2013 THERE HAVE BEEN NO FURTHER REPORTS OF THIS ISSUE WITH THIS DEVICE IN THE TRACKWISE DATABASE. THIS IS THE ONLY TRACKWISE RECORD FOR THIS DEVICE WITH THIS PROBLEM. THIS WAS A MALFUNCTION THAT CAUSED A POWER CONNECTION ISSUE. BECAUSE PHILIPS DID NOT RECREATE THE PROBLEM THE SPECIFIC CAUSE CANNOT BE DETERMINED. THE DEVICE WAS FOUND TO PASS PERFORMANCE CHECKS AND THE PROBLEM IS CONSIDERED RESOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS SWITCHING ON AND OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5578 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1