BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2220517 · Received July 18, 2011

    Report

    Report Number
    1218950-2011-02053
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Report Date
    June 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE AC POWER MODULE FAILED. THERE WAS NO REPORTED PT INVOLVEMENT. THE CUSTOMER REPLACED THE AC POWER MODULE WITH ONE OF THEIR OWN AND RESOLVED THE PROBLEM. THE AC POWER MODULE WAS NOT AVAILABLE FOR EVAL. WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC POWER MODULE FAILED. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS HEALTHCARE - ANDOVER M3539A

    Patients

    Seq Age Sex Outcome Treatment
    1