BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL

    MDR report key: 4196919 · Received October 15, 2014

    Report

    Report Number
    1218950-2014-06186
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE XL DEVICE CANNOT "BOOT UP". THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655198 HEARTSTART XL MJK PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1