BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 3032017 · Received March 6, 2013

    Report

    Report Number
    3023750-2013-00032
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K022453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    WELCH ALLYN FIELD SERVICE CONFIRMED THE HARD DISK DRIVE (HDD) FAILURE. WELCH ALLYN FIELD SERVICE REPLACED THE HDD AND SOFTWARE AND SYSTEM FILES WERE RELOADED. TESTING WAS PERFORMED AND WAS PASSED. THE DEVICE WAS RETURNED TO CLINICAL USE. HARD DISK DRIVES ARE OFF-THE-SHELF SUB-COMPONENTS 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 FAILURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR ACUITY HAD A HARD DISK DRIVE (HDD) FAILURE, THEY ATTEMPTED TO RUN THE FSCK, BUT IT FAILED TO COMPLETE AND REBOOT THE SYSTEM. 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 EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96510 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 6.40.01

    Patients

    Seq Age Sex Outcome Treatment
    1