BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2504008 · Received March 7, 2012

    Report

    Report Number
    3023750-2012-00015
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    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 EVAL IS NOT YET COMPLETE. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETE. WELCH ALLYN IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. IT IS UNCLEAR WHETHER THIS EVENT IS RELATED TO ACUITY OR NOT. THE INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SEVERAL PTS FAILED TO RECONNECT TO ACUITY AFTER LEAVING A COVERED AREA. IF A PT IS TAKEN OUT OF THE COVERAGE AREA FOR TREATMENT/PROCEDURE, THE BEDSIDE MAY FAIL TO RECONNECT WHEN RETURNING TO AN AREA WITH WIRELESS COVERAGE. IN SUCH CIRCUMSTANCES, THE STAFF HAS TO CYCLE THE POWER AT THE BEDSIDE MONITOR BY REMOVING THE BATTERY ON THE DEVICE IN ORDER TO RESTORE CONNECTIVITY WITH ACUITY. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY 8.10

    Patients

    Seq Age Sex Outcome Treatment
    1