BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL

    MDR report key: 3082945 · Received April 23, 2013

    Report

    Report Number
    1218950-2013-01453
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE CUSTOMER REPORTED THAT THE USERS DID AN OPERATIONAL CHECK WHILE THE DEVICE WAS CONNECTED TO A PATIENT. AS PART OF THE CHECK, WHEN THE UNIT DISCHARGED THE PATIENT RECEIVED A SHOCK. THE CUSTOMER REPORTED THAT THE ¿PATIENT HAS HAD COMPLICATIONS BUT IS NOW RECOVERING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173889 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1