BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2142680 · Received June 21, 2011

    Report

    Report Number
    1218950-2011-01759
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    May 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AC POWER MODULE AC CONNECTOR BROKE AND THE WIRES BECAME EXPOSED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. A REPLACEMENT AC POWER MODULE WAS SHIPPED TO THE CUSTOMER . WE WILL CONSIDER THIS A MALFUNCTION OF THE AC POWER MODULE THAT CAUSED THE AC POWER CONNECTOR TO BREAK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE AC CONNECTOR BROKE AND THE WIRES BECAME EXPOSED. THERE WAS NO REPORTED PATIENT 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