BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERATING ROOM TABLE ARMBOARD

    MDR report key: 22270 · Received June 7, 1995

    Report

    Report Number
    MW1006164
    Event Type
    Injury
    Date Received
    June 7, 1995
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    BWN
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RESULTS OF ANALYSIS BY THE MFR ON SIMILAR DEVICES INDICATE THAT EXCESSIVE WEAR CAN OCCUR ON A PORTION OF THE MOUNT THAT SECURES TO THE TABLE RAIL. WE BELIEVE THIS TO BE THE CASE WITH THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT AS WELL. AN EVALUATION OF COMPLAINTS INDICATES THAT THE REPORTED EVENT IS OCCURRING WITH GREATER FREQUENCY THAN IS USUAL FOR THE DEVICE: HOWEVER, THE ANALYSIS INDICATES THAT THE REPORTED EVENT IS NOT OCCURING AT THE SEVERITY REPORTED, I.E. NO INJURIES HAVE OCCURRED FROM THE REPORTED EVENT. AMSCO REMEDIAL ACTION PLANS ARE BEING FORMULATED & WILL INCLUDE REPLACEMENT OF THE AFFECTED MODEL REFERRED TO AS A ONE-STEP ARMBOARD, WITH A MODEL OF DIFFERENT DESIGN, REFERRED TO AS THE AMSCO I.V. ARMBOARD. THE AMSCO I.V. ARMBOARD WAS IN DISTRIBUTION PREVIOUSLY & HAS AN ESTABLISHED HISTORY OF CUSTOMER ACCEPTANCE. AMSCO DISCONTINUED DISTRIBUTION OF THE ONESTEP ARMBOARD DEVICE IN 3/95 & THE AMSCO I.V. ARMBOARD WAS REINTRODUCED THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERATING ROOM TABLE ARMBOARD OPERATING ROOM TABLE BWN AMERICAN STERILIZER CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention