BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2501738 · Received February 27, 2012

    Report

    Report Number
    1218950-2012-00655
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Report Date
    January 31, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO CHARGE IN OP CHECK. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. REPLACEMENT OF THE PROCESSOR PCA RESOLVED THE REPORTED SYMPTOM. THE DEVICE PASSED TESTING AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO CHARGE IN OP CHECK. 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-DUP M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1