BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILATOR

    MDR report key: 3037816 · Received March 4, 2013

    Report

    Report Number
    1218950-2013-00773
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Report Date
    February 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A DEFIB TEST FAILURE. IT WAS LATER CLARIFIED THEIR WAS A SHOCK FAILURE DURING THE OPERATIONAL CHECK. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE ISSUE WAS ISOLATED TO THE THERAPY PCA. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THIS WAS A MALFUNCTION OF THE THERAPY PCA THAT CAUSED THE REPORTED SYMPTOM. REPLACEMENT OF THE THERAPY PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DEFIB TEST FAILURE. IT WAS LATER CLARIFIED THEIR WAS A SHOCK FAILURE DURING THE OPERATIONAL CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92440 HEARTSTART MRX-EMS DEFIBRILATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1