BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2113602 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01433
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    PHILIPS MEDICAL
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A INTERMITTENT THERAPY FAILURE DURING THE OPERATIONAL CHECK. PHILIPS EVALUATED THE DEVICE. THE REPORTED SYMPTOM WAS NOT DUPLICATED. UPON INSPECTION OF THE DEVICE, IT WAS NOTED THAT THERAPY CONNECTOR WAS WORN. AS A PRECAUTIONARY MEASURE THE THERAPY CONNECTOR WAS REPLACED. WE ARE CONSIDERING THIS MOST CONSISTENT WITH A MALFUNCTION OF THE THERAPY CONNECTOR THAT CAUSED INTERMITTENT THERAPY FAILURE DURING OP CHECK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A INTERMITTENT THERAPY FAILURE DURING THE OPERATIONAL CHECK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1