BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2823660 · Received October 9, 2012

    Report

    Report Number
    1218950-2012-03372
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Report Date
    September 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO ECG STRIPS OR EVENT SUMMARY AVAILABLE FROM THE CUSTOMER FOR PHILIPS TO REVIEW. THE DEVICE PASSED TESTING BY THE HOSPITAL BIOMEDICAL ENGINEER. THE DEVICE AND ACCESSORIES WERE ALSO EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER, AND THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. AFTER PASSING ALL PERFORMANCE VERIFICATION TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER. WE CANNOT DETERMINE THE CAUSE OF THE FAILURE AS THE SYMPTOM WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER DELIVERING MULTIPLE SHOCKS WITH INTERNAL PADDLES THAT THERE WAS LATER A FAILURE TO DISCHARGE VIA PADS. THERE WAS NO NEGATIVE PATIENT IMPACT AS THE USERS SWITCHED TO A DIFFERENT DEFIBRILLATOR TO DELIVER THERAPY.

    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