BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2509401 · Received March 24, 2012

    Report

    Report Number
    1218950-2012-01011
    Event Type
    Malfunction
    Date Received
    March 24, 2012
    Report Date
    February 27, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE AC POWER MODULE WAS NOT CHARGING THE DEVICE. THERE WAS NO REPORTED PT INVOLVEMENT. THE PHILIPS REP ISOLATED THE ISSUE TO THE AC POWER MODULE. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE ISSUE. WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE WHERE THE DEVICE WOULD NOT CHANGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC POWER MODULE WAS NOT CHARGING THE DEVICE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS-DUP M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1