BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2080128 · Received April 6, 2011

    Report

    Report Number
    1218950-2011-00924
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    March 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 THAT THE UNIT SHOWED A "REPLACE BATTERY" INOP. HE BELIEVED THAT THE AC POWER MODULE WAS INTERMITTENTLY FAILING AND THAT CAUSED THE INOP. THE CUSTOMER ORDERED A NEW AC POWER MODULE WHICH RESOLVED THE ISSUE. A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO STATED THAT THE DEVICE IS BACK IN SERVICE WITH THE NEW AC POWER MODULE INSTALLED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHOWED A "REPLACE BATTERY" INOP.

    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