BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2160521 · Received July 5, 2011

    Report

    Report Number
    1218950-2011-01921
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Report Date
    June 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    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 REPORTED THE AC POWER MODULE WIRES CAME OUT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE AC POWER MODULE WAS NOT AVAILABLE FOR EVALUATION. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE ISSUE. WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE THAT COULD PREVENT THE DEVICE FROM POWERING UP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC POWER MODULE WIRES CAME OUT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1