BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3090126 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01409
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 28, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE TECHNICIAN. THE REPORTED SYMPTOM WAS CONFIRMED. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE SYMPTOM. AFTER PASSING ALL TESTING THE DEVICE WAS RETURNED TO SUE. WE WILL CONSIDER THIS A PROCESSOR PCA MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE DEFIB TEST; IT FAILED TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169498 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1