BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 3063267 · Received February 26, 2013

    Report

    Report Number
    1218950-2013-00662
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    January 30, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN AC POWER MODULE FAILURE AND NEEDED TO ORDER A NEW AC POWER MODULE. THERE WAS NO REPORT PATIENT INVOLVEMENT. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN AC POWER MODULE FAILURE AND NEEDED TO ORDER A NEW AC POWER MODULE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81946 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A REV F_0938C

    Patients

    Seq Age Sex Outcome Treatment
    1