BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC POWER MODULE

    MDR report key: 2880988 · Received November 13, 2012

    Report

    Report Number
    1218950-2012-03760
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 21, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS AUTHORIZED SUPPORT PERSONNEL EVALUATED THE DEVICE AND CONFIRMED THE REPORTED COMPLAINT. IT WAS FOUND THAT THE AC POWER MODULE CONNECTOR HAD PULLED OUT FROM THE HOUSING. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE PROBLEM. THIS IS A MALFUNCTION OF THE AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAS A POWER PLUG (CONNECTOR ON AC POWER MODULE) THAT HAS BEEN PULLED OUT OF THE MACHINE. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC POWER MODULE MKJ PHILIPS MEDICAL SYSTEMS M3539A API1AD41-000 F 0945 C

    Patients

    Seq Age Sex Outcome Treatment
    1