BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3060678 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01049
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER INITIALLY REPORTED AN UNSPECIFIED AED ISSUE. THE SYMPTOM WAS LATER CLARIFIED TO BE THAT THE CUSTOMER WAS EXPECTING TO SELECT ENERGY IN THE AED MODE DURING TESTING AND THOUGHT THERE WAS A MALFUNCTION. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE ISSUE WAS ISOLATED TO A USE ERROR WHERE THE USER WAS NEW TO THE DEVICE AND THOUGHT THEY COULD SELECT AN ENERGY IN THE AED MODE. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. THE PHILIPS FSE INSTRUCTED THE USER ON AED FUNCTIONALITY. THERE IS NO REQUEST FOR A RESPONSE BY THE CUSTOMER. THE SYMPTOM REPORTED WAS RESULT OF A USE ERROR AND NOT A MALFUNCTION OF THE DEVICE. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED AN UNSPECIFIED AED ISSUE. THERE WAS NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122995 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1