BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2120392 · Received May 27, 2011

    Report

    Report Number
    3023750-2011-00041
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 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

    OUR INVESTIGATION IS ONGOING. AT THIS POINT WE DO NOT BELIEVE THE ACUITY SYSTEM APS ACTUALLY MALFUNCTIONED IN A MANNER THAT CAUSED DROPOUTS, NOR HAVE ANY ADVERSE EVENTS BEEN REPORTED RELATED TO THESE DROPOUTS. NONETHELESS, BECAUSE THE INVESTIGATION HAS NOT YET CONCLUDED, WE ARE FILING THIS AS MALFUNCTION MDR IN AN ABUNDANCE OF CAUTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. UPGRADE TO WIRELESS NETWORK DEACTIVATED DURING INVESTIGATION OF DROPOUTS. NOTE: THE CUSTOMER INDICATED THE PROBLEM OCCURRED IN MULTIPLE LOCATIONS WITHIN THE FACILITY. THEREFORE, IN ADDITION TO THE ACUITY CENTRAL MONITORING SYSTEM REFERRED ON THIS REPORT, THE FOLLOWING ACUITY CENTRAL STATIONS ALSO WERE INVOLVED: SERIAL NUMBER (B)(4); SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY ARE GETTING DROPOUT OF THEIR BEDSIDE MONITORS IN MULTIPLE LOCATIONS WITHIN THE FACILITY AFTER AN UPGRADE TO THEIR WIRELESS NETWORK. THIS PROBLEM OCCURRED OVER SEVERAL DAYS AND HAD BEEN GETTING PROGRESSIVELY WORSE. WELCH ALLYN TECHNICAL SUPPORT REMOTELY ASSISTED THE CUSTOMER BY POWER CYCLING ALL AP'S (ACCESS POINT) ON THE FACILITY TO FIX THE PROBLEM. ACCORDING TO THE CUSTOMER IT HELPED THE DROPOUTS BUT DID NOT COMPLETELY REMEDY THE ISSUE. WELCH ALLYN FIELD ENGINEERING WAS DISPATCHED TO THE SITE TO TROUBLESHOOT THE PROBLEM. AS A RESULT, THE CUSTOMER TEMPORARILY LOST THE ABILITY TO MONITOR SOME PATIENTS FROM A CENTRAL LOCATION IN MULTIPLE INSTANCES. 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