BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PADDLES

    MDR report key: 4012112 · Received July 11, 2014

    Report

    Report Number
    1218950-2014-04040
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL DEFIBRILLATOR PADDLE CHARGE AND RECHARGE BUTTONS WERE NOT WORKING. THERE WAS NO ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408128 EXTERNAL PADDLES MKJ PHILIPS MEDICAL SYSTEMS M47461

    Patients

    Seq Age Sex Outcome Treatment
    1