BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 4161696 · Received July 23, 2014

    Report

    Report Number
    1218950-2014-04266
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 1, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEART START XL DEFIBRILLATOR INTERNAL PADDLES DID NOT FIRE DURING PATIENT USE. THERE WAS NO ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430031 HEART START XL MKJ MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1