BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO 3085 SP

    MDR report key: 5107190 · Received September 28, 2015

    Report

    Report Number
    5107190
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 9, 2015
    Manufacturer
    STERIS CORPORATION
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HAND CONTROL DISPLAYED RUNNING ON BATTERY POWER, NOT AC. CALLED MANUFACTURER SERVICE REP, COULD NOT DUPLICATE PROBLEM, BED RETURNED TO SERVICE. THREE WEEKS LATER, ISSUE RECURRED, CALLED MANUFACTURER, VENDOR SERVICE REP ON SITE, REPLACED POWER SUPPLY BOARD. NO PATIENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639793 AMSCO 3085 SP TABLE, OPERATING-ROOM, AC-POWERED FQO STERIS CORPORATION 3085 SP

    Patients

    Seq Age Sex Outcome Treatment
    1