BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX

    MDR report key: 3902826 · Received February 20, 2014

    Report

    Report Number
    3030677-2014-00635
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Report Date
    February 4, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY PENDING RETURN FOR DEVICE EVALUATION. DEVICE MFR DATE: 01/2011.

    Description of Event or Problem · 1

    AFTER DEPLOYING A DEVICE, THE USER ATTEMPTED TO DOWNLOAD PT USE EVENT DATA. AT THAT TIME, THE DEVICE EMITTED A TRIPLE CHIRP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106924 HEARTSTART FRX MKJ PHILIPS MEDICAL SYSTEMS 861304

    Patients

    Seq Age Sex Outcome Treatment
    1