BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1841482 · Received September 16, 2010

    Report

    Report Number
    1218950-2010-01609
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Report Date
    August 4, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED GETTING AN X MARK. THERE WAS NOT ENOUGH INFO TO MAKE A REPORTABILITY DETERMINATION. A PHILIPS FIELD SERVICE ENGINEER CLARIFIED THE SYMPTOM AS A FAILURE TO POWER UP, A REPORTABLE MALFUNCTION. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THIS REPORT IS CANCELLED BECAUSE, CURRENTLY MDR IS BEING USED IN PLACE OF THE SPECIFIC REGION REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1