BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C POWER MODULE

    MDR report key: 3090134 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01417
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER PERFORMED THE EVALUATION AND IDENTIFIED THE AC POWER MODULE FAILURE. THE CUSTOMER WAS PROVIDED A PART ID AND SUPPLIES CONTACT INFORMATION TO ORDER A REPLACEMENT AC POWER MODULE. BASED ON THE CUSTOMER REPORT WE ARE CONSIDERING THIS A MALFUNCTION OF THE AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE IS NOT WORKING. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169689 C POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1