BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2050519 · Received April 5, 2011

    Report

    Report Number
    1218950-2011-00888
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT WHEN THEY PULLED THE POWER CORD OUT OF THE AC POWER MODULE, THE CONNECTOR WIRES SPLIT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THEY PULLED THE POWER CORD OUT OF THE AC POWER MODULE, THE CONNECTOR WIRES SPLIT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1