BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2142590 · Received June 21, 2011

    Report

    Report Number
    1218950-2011-01761
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    May 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT THE DEVICE HAD SHOCK/PACER EQUIPMENT MALFUNCTION AND CLICKING NOISES. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED AT PHILIPS AND AUTOTEST FAILURES FOR CHARGE AND SHOCK WERE NOTED. REPLACEMENT OF THE THERAPY PCA RESOLVED THE SYMPTOM.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THE DEVICE HAD SHOCK/PACER EQUIPMENT MALFUNCTION AND CLICKING NOISES. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1