BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2860468 · Received November 5, 2012

    Report

    Report Number
    1218950-2012-03687
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Report Date
    October 9, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE'S AC POWER MODULE WAS NOT WORKING AND THE GREEN LIGHT DID NOT LIGHT UP. THERE WAS NO PT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE'S AC POWER MODULE WAS NOT WORKING AND THE GREEN LIGHT DID NOT LIGHT UP. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1