BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2503263 · Received March 21, 2012

    Report

    Report Number
    3023750-2012-00017
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 25, 2012
    Report Date
    February 25, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. AS INDICATED IN THE COMPLAINT, THE CUSTOMER REPORTED THAT THE ACUITY CENTRAL STATION CENTRAL PROCESSING UNIT (CPU) WOULD NOT POWER ON. ACUITY PRODUCT SERVICE CONFIRMED THAT THE CENTRAL PROCESSING UNIT (CPU) HAD A DEFECTIVE POWER SUPPLY AND WOULD NOT POWER UP. THE FAULTY POWER SUPPLY WAS REPLACED AND THE UNIT WORKED AS INTENDED. THE REPAIRED CPU POWERED ON WITH NO ERRORS AND PASSED ALL FUNCTIONAL TESTS. THE POWER SUPPLY IS A SUB-ASSEMBLY OF A PURCHASED, OFF-THE SHELF, SUN PLATFORM CENTRAL PROCESSING UNIT (CPU). WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUBCOMPONENTS AS THE SOURCE OF FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT ACUITY CPU WOULD NOT POWER ON. THIS RESULTED IN A LOSS OF CENTRALIZED MONITORING; HOWEVER, BESIDE MONITORING WAS NOT AFFECTED. 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. PLATFORM CPU

    Patients

    Seq Age Sex Outcome Treatment
    1