BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURB FR2+ AED, WITH ECG, CANTONESE

    MDR report key: 4063199 · Received August 8, 2014

    Report

    Report Number
    3030677-2014-01853
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    August 6, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    003565
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION PENDING. ISSUE IS BEING REPORTED AS ALERT COULD NOT BE CLEARED BY OPERATOR.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE AED VOICE PROMPTS ARE NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470639 REFURB FR2+ AED, WITH ECG, CANTONESE MKJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1