BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1852737 · Received September 25, 2010

    Report

    Report Number
    1218950-2010-01710
    Event Type
    Malfunction
    Date Received
    September 25, 2010
    Report Date
    July 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INITIALLY REPORTED THAT THE AC POWER MODULE INLET HAD PULLED OUT. AT THAT TIME, THE CUSTOMER DID NOT REPORT THAT THE AC POWER MODULE HAD FAILED TO WORK. THE CUSTOMER ORDERED A NEW POWER MODULE, WHICH RESOLVED THE FAILURE, ON (B)(6) 2010, THE CUSTOMER CLARIFIED THAT, IN ADDITION TO THE INLET PULLING OUT, THE MODULE HAD FAILED TO POWER UP THE UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE AC POWER MODULE INLET HAD PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1