BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2212720 · Received July 12, 2011

    Report

    Report Number
    1218950-2011-01961
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE AC POWER MODULE FAILED. THERE WAS NO REPORTED PT INVOLVEMENT. THE AC POWER MODULE WAS NOT AVAILABLE FOR EVALUATION. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE ISSUE. WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE THAT CAUSED THE AC MODULE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 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