BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEART START XL

    MDR report key: 1637733 · Received March 18, 2010

    Report

    Report Number
    1218950-2010-00356
    Event Type
    Other
    Date Received
    March 18, 2010
    Report Date
    February 22, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE ISSUE HAD BEEN THE RESULT OF THE PT IMPEDANCE BEING TOO HIGH, AND NO MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING A NO SHOCK DELIVERED MESSAGE. NO ADVERSE PT IMPACT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1