BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORERUNNER AED, US ENGLISH - NO DISPLAY

    MDR report key: 3772044 · Received December 31, 2013

    Report

    Report Number
    3030677-2013-02285
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Report Date
    December 23, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    013425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED AS ISSUE COULD NOT BE CLEARED BY OPERATOR. DUE TO THE AGE OF THE DEVICE, 14 YEARS, THE DEVICE WILL NOT BE REPLACED. CUSTOMER ADVISED TO REMOVE FROM SERVICE. DATE OF MANUFACTURE: JULY 1999.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED DID NOT PASS SELF DIAGNOSTIC CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683119 FORERUNNER AED, US ENGLISH - NO DISPLAY MKJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1