BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2102307 · Received May 18, 2011

    Report

    Report Number
    1218950-2011-01411
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    April 21, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PACEMAKER OF THE DEVICE WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT IMPACT OR INVOLVEMENT. THE DEVICE WAS EVALUATED BY PHILIPS AND THERE WAS NO TROUBLE FOUND. THE DEVICE PASSED ALL STANDARD TESTING. THE AVAILABLE INFORMATION DOES NOT SUPPORT THAT A MALFUNCTION OCCURRED. THE USERS WERE PROVIDED WITH INFORMATION ON PERFORMING AN OPCHECK CORRECTLY AND THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PACEMAKER OF THE DEVICE WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT IMPACT OR INVOLVEMENT.

    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