BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1082718 · Received July 22, 2008

    Report

    Report Number
    3023750-2008-00179
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 21, 2008
    Report Date
    June 23, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED BUT IS ANTICIPATED. A SUPPLEMENTAL WILL BE SUBMITTED UPON ITS RETURN AND COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHEN THE DEVICE IS TURNED ON, THE SCREEN IS SCRAMBLED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC 50

    Patients

    Seq Age Sex Outcome Treatment
    1