BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2091283 · Received May 4, 2011

    Report

    Report Number
    3023750-2011-00034
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 WIRED OR WIRELESS CONNECTIONS. WELCH ALLYN TECHNICAL SUPPORT ASSISTED THE CUSTOMER AND REPLACED THE FAILED DISPLAY. WELCH ALLYN FACTORY SERVICE CONFIRMED THAT THE MONITOR HAD FAILED. THE DISPLAY IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MANUFACTURER AND SOLD BY WELCH ALLYN. WE DO NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCES OF FAILURE. THEREFORE, NO FURTHER FAILURE INVESTIGATION CAN BE PERFORMED. METHOD (REPLACED PER SERVICE CONTRACT).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS PLR DISPLAY TURNS ITSELF OFF AFTER A FEW SECONDS. NO LOSS OF CENTRALIZED MONITORING. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE ANY PT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 7.02.00

    Patients

    Seq Age Sex Outcome Treatment
    1