BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2113610 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01462
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING THE DEFIBRILLATION ENERGY WAS LOW. THERE WAS NO PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE, CONFIRMED THE MALFUNCTION, AND RESOLVED THE MALFUNCTION BY REPLACING THE POWER PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING THE DEFIBRILLATION ENERGY WAS LOW. THERE WAS NO PT 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