BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 1982523 · Received January 11, 2011

    Report

    Report Number
    1218950-2011-00101
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Report Date
    December 14, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AC POWER MODULE FAILED AND THAT THE UNIT FAILED TO POWER UP ON AC POWER. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS NOT EVALUATED BY PHILIPS. THE CUSTOMER ORDERED A NEW AC POWER MODULE WHICH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE FAILED AND THAT THE UNIT FAILED TO POWER UP ON AC POWER. THERE WAS NO REPORT OF PT INVOLVEMENT.

    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