BEUDAMED
    FDA Adverse Event Summary report: N

    ANESTHESIA ARMBOARD DEVICE

    MDR report key: 4210859 · Received October 29, 2014

    Report

    Report Number
    1043572-2014-00107
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 29, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS ACCOUNT MANAGER RECEIVED PHOTOGRAPHS OF THE ARMBOARDS FROM THE (B)(6) MEDICAL CENTER EQUIPMENT COORDINATOR. BOTH ARMBOARDS SHOW FRACTURING TYPICAL OF AN UPWARD FORCE. SPLINTERING OR CRACKING OF THE LAMINATION ON THE CARBON FIBER MAY OCCUR IF THE TABLE IS ARTICULATED IN "FLEX" OR "REFLEX" POSITION AND AN UPWARD FORCE IS EXERTED ON THE ARMBOARD. THE ANESTHESIA ARMBOARD DEVICE SPECIFICATION ((B)(4)) SECTION 4.8 STATES THE "EXPECTED USEFUL LIFE [IS] 5 YEARS UNDER NORMAL USE." THE ARMBOARD SERIAL NUMBER (B)(6) INDICATES THAT THIS ACCESSORY WAS MADE ON (B)(6) 2002. THE SERIAL NUMBER OF THE SECOND ARMBOARD COULD NOT BE IDENTIFIED AS THE SERIAL NUMBER LABEL WAS TORN FROM THE ARMBOARD. EACH ARMBOARD HAS A WARNING LABEL STATING, "CHECK ACCESSORY FOR DAMAGE OR WEAR PRIOR TO EACH USE". AS STATED IN THE INSTRUCTIONS FOR USE, "WARNING - SAFEGUARD PATIENT: CRACKED OR SPLINTERED SURFACES MAY CAUSE INJURY. INSPECT ALL SURFACES AND HARDWARE PRIOR TO USE. DAMAGED ARMBOARD MUST BE REPLACED. READ AND UNDERSTAND ALL INSTRUCTIONS PRIOR TO USING THE ANESTHESIA ARMBOARD. DO NOT USE EQUIPMENT IF WORN, DAMAGED, OR PIECES ARE MISSING." THE ARMBOARDS SUBJECT OF THE REPORTED EVENT HAVE BEEN REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE TABLE ARM BOARDS ARE SPLINTERING. NO INJURIES OR PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694019 ANESTHESIA ARMBOARD DEVICE ARMBOARD FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1