BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2941769 · Received December 21, 2012

    Report

    Report Number
    1218950-2012-04119
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    January 10, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE CANNOT BE SWITCHED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE. THE ISSUE WAS CLARIFIED AS A FAILURE TO POWER UP. THE PROBLEM WAS ISOLATED TO THE ENERGY SELECT SWITCH. (B)(4) WAS APPLIED TO THIS DEVICE TO RESOLVE THE ISSUE, WHICH CONSISTS OF REPLACING THE ENERGY SELECT SWITCH. THE DEVICES AFFECTED BY THIS FCO ARE LISTED BY SERIAL NUMBER. THIS DEVICE IS WITHIN THE FCO SERIAL NUMBER RANGE. AFTER PASSING ALL PERFORMANCE ASSURANCE TESTS THE DEVICE WAS RETURNED TO THE CUSTOMER NO FURTHER COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED. THIS WAS A MALFUNCTION OF THE ENERGY SELECT SWITCH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE CANNOT BE SWITCHED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    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