BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3012507 · Received February 20, 2013

    Report

    Report Number
    3023750-2013-00021
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED CONFIRMED THAT THE DISPLAY FAILED. THE VIEWSONIC DISPLAY IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MANUFACTURER AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCE OF THE FAILURE. METHOD - (BIOMET CONFIRMED DISPLAY FAILURE).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR MONITOR FAILED; DOES NOT POWER UP. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. THE CUSTOMER DID NOT PROVIDE ANY PT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74828 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. DISPLAY,19", ANA

    Patients

    Seq Age Sex Outcome Treatment
    1