BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2150390 · Received June 8, 2011

    Report

    Report Number
    3023750-2011-00044
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY HAVE A PATIENT WAS ON SPO2 ONLY AND DURING TRANSPORT THE PATIENT DROPPED OUT. THE CONCERN WITH THIS PATIENT IS NOT THE DROPOUT, BUT INSTEAD THE BEHAVIOR OF THE SYSTEM, WHEN THE DROPOUT OCCURRED. WHEN THE CONNECTION DROPPED OUT, THE TILE DID NOT TURN YELLOW (INDICATING DROPOUT) BUT INSTEAD IT DISAPPEARED FROM THE ACUITY SYSTEM COMPLETELY. AS A RESULT, THE CUSTOMER TEMPORARILY LOST THE ABILITY TO MONITOR THIS FROM A CENTRAL LOCATION. BEDSIDE MONITORING WAS NOT AFFECTED. THERE WAS NO REPORT OF ANY PATIENT HARM AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE SPECIFIC PATIENT IDENTIFIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY SW 7.10.01

    Patients

    Seq Age Sex Outcome Treatment
    1