BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2943420 · Received January 8, 2013

    Report

    Report Number
    1218950-2013-00079
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 11, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN AC POWER MODULE FAILURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE DEVICE WAS NOT EVALUATED BY PHILIPS. THE PHILIPS RESPONSE CENTER PROVIDED THE CUSTOMER WITH PARTS ORDERING INFORMATION. BASED ON THE INFORMATION AVAILABLE, WE WILL CONSIDER THIS AN AC POWER MALFUNCTION. AS OF 01/02/2013 THERE HAVE BEEN ON FURTHER CALLS FROM THE CUSTOMER REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN AC POWER MODULE FAILURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10387 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1