BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2051860 · Received March 14, 2011

    Report

    Report Number
    1218950-2011-00686
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER A SHOCK IN THE SYNC MODE DURING A CARDIOVERSION PROCEDURE. THERE WAS NO REPORT OF NEGATIVE IMPACT TO THE INVOLVED PT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER A SHOCK IN THE SYNC MODE DURING A CARDIOVERSION PROCEDURE. THERE WAS NO REPORT OF NEGATIVE IMPACT TO THE INVOLVED PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1