BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2604874 · Received June 4, 2012

    Report

    Report Number
    1218950-2012-01835
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Report Date
    May 8, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT TURN ON. THERE WAS NO REPORTED PATIENT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE BATTERY PCA WAS FOUND TO HAVE BENT PINS. THE BATTERY PCA WAS REPLACED TO RESOLVE THE PROBLEM. AFTER PASSING ALL PERFORMANCE ASSURANCE TESTING, THE DEVICE WAS RETURNED TO USE. THE DAMAGED BATTERY PCA CAUSED THE FAILURE TO POWER UP. WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THE BENT BATTERY PCA PINS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT TURN ON. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1