BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2914178 · Received December 7, 2012

    Report

    Report Number
    1218950-2012-04039
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 15, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO PHILIPS FOR EVALUATION BY THE REPAIR BENCH. THE REPORTED SYMPTOM WAS CONFIRMED. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE SYMPTOM. THE DEVICE PASSED AL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RED X ON THE DEVICE WOULD NOT CLEAR. THERE WAS NO PT 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