BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 1941209 · Received December 9, 2010

    Report

    Report Number
    3023750-2010-00167
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K252160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 MULTIFUNCTIONAL PT MONITORING DEVICES THROUGH EITHER WIRED OR WIRELESS CONNECTIONS. WELCH ALLYN FACTORY SERVICE COULD NOT CONFIRM THE MALFUNCTION. CUSTOMER DID NOT RETURN THE POWER ADAPTER USED FOR THIS MONITOR. DUE TO THE AGE OF THE PRODUCT AND THE FACT THAT IT HAS BEEN OBSOLETE ACUITY SERVICE DOES NOT HAVE THE TYPE OF POWER ADAPTER TO PROVIDE POWER TO THIS MONITOR. NO FURTHER FAILURE INVESTIGATION IS POSSIBLE AND THE MONITOR HAS BEEN REPLACED. THE DISPLAY IS AN OFF-THE-SHELF COMPUTER PERIPHERAL MADE BY ANOTHER MANUFACTURER AND SOLD BY (B)(4). (B)(4) DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCES OF FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEIR SONY FLAT PANEL DISPLAY FOR THE ACUITY CENTRAL MONITORING STATION FAILED. THIS RESULTED IN A TEMPORARY INABILITY TO MONITOR PT'S CENTRALLY UNTIL THE CUSTOMER REPLACED THE MONITOR. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS. NOTE: 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. 7.10.01

    Patients

    Seq Age Sex Outcome Treatment
    1