BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2041449 · Received March 9, 2011

    Report

    Report Number
    1218950-2011-00605
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Report Date
    February 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO PHILIPS THAT THE UNIT FAILED TO POWER UP. IT WAS EVALUATED LOCALLY BY THE CUSTOMER. THE CUSTOMER ISOLATED THE ISSUE TO THE A/C POWER MODULE. REPLACING THE POWER MODULE RESOLVED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS THAT THE UNIT FAILED TO POWER UP.

    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