BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2231236 · Received July 22, 2011

    Report

    Report Number
    1218950-2011-02091
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER CONTACTED PHILIPS TO REPORT DIFFICULTY PACING A PT WITH THIS DEFIBRILLATOR. THERE WAS NO NEGATIVE IMPACT TO THE INVOLVED PT. OUR INVESTIGATION DETERMINED THAT THE CLINICIAN WAS USING A NON-PHILIPS THERAPY CABLE WHEN ATTEMPTING PACING. THE CUSTOMER WAS ADVISED THAT USE OF THE PHILIPS DEFIBRILLATOR REQUIRES A PHILIPS THERAPY CABLE. THIS REPORT IS CONSISTENT WITH A USE ISSUE.

    Description of Event or Problem · 1

    THIS CUSTOMER CONTACTED PHILIPS TO REPORT DIFFICULTY PACING A PT WITH THIS DEFIBRILLATOR. THERE WAS NO NEGATIVE IMPACT TO THE INVOLVED PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1