BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2002644 · Received February 9, 2011

    Report

    Report Number
    1218950-2011-00341
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Report Date
    January 10, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AC POWER MODULE HAD FAILED AND WAS NOT CHARGING THE BATTERY. THE CUSTOMER ORDERED A NEW AC POWER MODULE WHICH RESOLVED THE FAILURE. AS OF (B)(6) 2011, THERE HAVE BEEN NO FURTHER REPORTS OF THIS ISSUE FROM THIS CUSTOMER SITE. THE UNIT REMAINS AT THE CUSTOMER SITE WITH THE NEW MODULE INSTALLED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE HAD FAILED AND WAS NOT CHARGING THE BATTERY.

    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