BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2043221 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00694
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE BATTERY WAS NOT CHARGING DUE TO THE AC POWER MODULE FAILING. THERE WAS NO REPORT OF PT INVOLVEMENT. GIVEN THE SYMPTOMS REPORTED THE PHILIPS DETERMINED THAT THE AC POWER MODULE HAD FAILED. ON (B)(4) 2011, THE AC POWER MODULE WAS ORDERED AND SHIPPED TO THE CUSTOMER. AS OF (B)(4) 2011, THERE HAVE BEEN NO FURTHER REPORTS OF THIS ISSUE FROM THIS CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY WAS NOT CHARGING DUE TO THE AC POWER MODULE FAILING.

    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