BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2043208 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00709
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AC POWER MODULE WAS FAULTY. THERE WAS NO REPORT OF PT INVOLVEMENT. THE LOCAL PHILIPS CUSTOMER CARE CENTER DETERMINED THAT THE AC POWER MODULE HAD FAILED. THE AC POWER MODULE WAS ORDERED FOR REPLACEMENT WHICH RESOLVED THE FAILURE. AS OF (B)(6) 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 AC POWER MODULE WAS FAULTY. 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