BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2980492 · Received January 31, 2013

    Report

    Report Number
    1218950-2013-00349
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 11, 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 REPORTED THAT THE ENERGY SELECTION SWITCH WAS NOT WORKING PROPERLY. THIS WAS DISCOVERED DURING TESTING; THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE SYMPTOM WAS CLARIFIED AS THE DEVICE FAILED TO POWER UP. THE FSE DETERMINED THAT THE ENERGY SELECT SWITCH WAS DEFECTIVE. THE CUSTOMER WAS GIVEN A QUOTE TO REPLACE THE ENERGY SELECT SWITCH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ENERGY SELECTION SWITCH WAS NOT WORKING PROPERLY. THIS WAS DISCOVERED DURING TESTING; THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43802 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1