BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2512581 · Received March 28, 2012

    Report

    Report Number
    3023750-2012-00019
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN INSTALLED CENTRALIZED PT MONITORING SYSTEM THAT UTILIZES A SUN MICROSYSTEMS CENTRAL PROCESSING UNIT (CPU) AND RELATED COMPUTER NETWORK PERIPHERALS. THE DEVICE RECEIVES, ANALYZES, AND DISPLAYS PT VITAL SIGNS DATA FROM MULTIPLE BEDSIDE MULTI-PARAMETER PT MONITORING DEVICES THROUGH EITHER WIRES OR WIRELESS CONNECTIONS. WELCH ALLYN TECHNICAL SUPPORT RECEIVED THE DISPLAY FROM THE CUSTOMER AND CONFIRMED THE ALLEGATION THAT THE DISPLAY FAILED AND WOULD NOT POWER ON. WELCH ALLYN REPLACED THE DISPLAY PER THE SERVICE CONTRACT. (REPLACED PER SERVICE CONTRACT).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A VIEWSONIC (B)(4) DISPLAY THAT FAILED (NO POWER). THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. MONITOR, VG930M

    Patients

    Seq Age Sex Outcome Treatment
    1