BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060647 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01074
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FSE THE REPORTED SYMPTOM WAS CONFIRMED AND ISOLATED TO THE ECG TRUNK CABLE. THE ECG TRUNK CABLE WAS REPLACED TO RESOLVE THE REPORTED SYMPTOM. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THIS WAS A MALFUNCTION OF THE ECG TRUNK CABLE. REPLACEMENT OF THE TRUNK CABLE RESOLVED THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    THE DEVICE WAS EVALUATED BY A PHILIPS FSE THE REPORTED SYMPTOM WAS CONFIRMED AND ISOLATED TO THE ECG TRUNK CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124893 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1