BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC POWER MODULE

    MDR report key: 3202277 · Received June 25, 2013

    Report

    Report Number
    1218950-2013-02651
    Event Type
    Death
    Date Received
    June 25, 2013
    Date of Event
    May 8, 2013
    Report Date
    June 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MRX SHUT DOWN UNEXPECTEDLY DURING USE ON A PT. THE INVOLVED PT DIED. HOWEVER, THE CUSTOMER HAS STATED THAT THE DEVICE BEHAVIOR DID NOT IMPACT THE PT OUTCOME AS THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288572 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1