BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART START XL

    MDR report key: 3161819 · Received June 6, 2013

    Report

    Report Number
    1218950-2013-02186
    Event Type
    Death
    Date Received
    June 6, 2013
    Report Date
    May 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFO CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING A PT EVENT. A SECOND DEFIBRILLATOR WAS RETRIEVED FOR USE ON THE PT HOWEVER THE INVOLVED PT DIED. WE DO NOT YET KNOW WHETHER THE DEVICE BEHAVIOR IMPACTED THE PT OUTCOME. THE DATE OF DEATH IS NOT KNOWN. WE HAVE REQUESTED ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251625 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death