BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART XL + DEFIBRILLATOR/MONITOR

    MDR report key: 3955299 · Received July 21, 2014

    Report

    Report Number
    1218950-2014-04244
    Event Type
    Death
    Date Received
    July 21, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 15, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    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 THEY HAD AN ISSUE WITH PACING IN DEMAND MODE. THE INVOLVED PATIENT DIED, BUT THE CUSTOMER STATED THAT THE DEVICE DID NOT IMPACT PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425611 HEARTSTART XL + DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1 Death