BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 4160751 · Received July 23, 2014

    Report

    Report Number
    1218950-2014-04249
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DEVICE A/C POWER MODULE WAS NOT HOLDING CHARGE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME ISSUE WAS DISCOVERED AND THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430747 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1