BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2941991 · Received December 22, 2012

    Report

    Report Number
    1218950-2012-04244
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A PACING FAILURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE POWER PCA WAS REPLACED TO RESOLVE THE FAILURE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCES TESTS AND WAS PLACED BACK INTO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PACING FAILURE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    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