BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORERUNNER AED, US ENGLISH, REFURB

    MDR report key: 2901433 · Received January 2, 2013

    Report

    Report Number
    3030677-2013-00004
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 27, 2012
    Manufacturer
    PHILIPS MEDICLA SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    013425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO AGE OF DEVICE, CUSTOMER HAS BEEN ADVISED TO REMOVE FROM SERVICE.

    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
    341 FORERUNNER AED, US ENGLISH, REFURB MKJ PHILIPS MEDICLA SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1