BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3023074 · Received February 27, 2013

    Report

    Report Number
    3023750-2013-00023
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K022453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BMET CONFIRMED THAT THE CPU COOLING FAN FAILED. WELCH ALLYN TECH SERVICE ASSISTED THE BMET IN TROUBLESHOOTING THE PROBLEM. THE BMET VERIFIED THAT THE CPU FAN IS MAKING LOUD NOISES AND NOT SPINNING WELL. THE SYSTEM IS AN OLD SYSTEM THAT IS NO LONGER REPAIRABLE AT WELCH ALLYN. THE BMET SAID HE WOULD LOOK INTO WHAT HE COULD DO TO REPAIR THE FAN AT THEIR SITE. THIS SYSTEM IS SUBJECT OF AN END OF LIFE LETTER TO CUSTOMER AND IS NO LONGER REPAIRABLE AT WELCH ALLYN. THE ACUITY COOLING FAN IS AN OFF-THE-SHELF COMPUTER SUB-COMPONENT MADE BY ANOTHER MANUFACTURER AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSESS TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUB-COMPONENTS AS THE SOURCE OF THE FAILURE. METHOD: (BMET CONFIRMED FAILURE).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR ACUITY SYSTEM LOCKED UP AND HAD A SCRAMBLED SCREEN. UPON SUBSEQUENT REBOOT HE GETS THE ERROR "CPU FAN NOT STARTING. - HOT." THIS RESULTED IN A TEMPORARY INABILITY TO CENTRALLY MONITOR PATIENTS, HOWEVER BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENTS. THE CUSTOMER DID NOT PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85006 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 6.31.00

    Patients

    Seq Age Sex Outcome Treatment
    1