BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3100027 · Received April 26, 2013

    Report

    Report Number
    1218950-2013-01496
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 5, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER ALLEGES THAT THE DEVICE SPONTANEOUSLY DISCHARGED AT 20J WHILE A USER WAS PERFORMING CPR. THEY ALLEGE THAT THE USER WAS POSSIBLE SHOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181759 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1