BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2485402 · Received March 7, 2012

    Report

    Report Number
    3030677-2012-00177
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Report Date
    February 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PENDING. BATTERY MODEL M3849A USED FOR FR2 M3860 AED 510(K) 014157.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT AED INDICATED "LOW BATTERY" DURING DEPLOYMENT. AT THIS TIME ASSOCIATED PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA MKJ PHILIPS MEDICAL SYSTEMS (HTST) NA 47303P

    Patients

    Seq Age Sex Outcome Treatment
    1