BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY CENTRAL MONITORING

    MDR report key: 2143583 · Received June 3, 2011

    Report

    Report Number
    3023750-2011-00049
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K052160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAVE AN ACUITY CENTRAL MONITORING SYSTEM THAT DID NOT ALARM WHEN A PT WAS IN BRADYCARDIA/ASYSTOLE. HOWEVER, BEDSIDE MONITORING WAS NOT AFFECTED. THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY CENTRAL MONITORING DSI WELCH ALLYN PROTOCOL, INC. ACUITY S/W 7.02.00

    Patients

    Seq Age Sex Outcome Treatment
    1