BEUDAMED
    FDA Adverse Event Summary report: N

    STIERIEN MAQUET ARM BOARD

    MDR report key: 9876 · Received July 29, 1993

    Report

    Report Number
    9876
    Date Received
    July 29, 1993
    Date of Event
    September 23, 1992
    Report Date
    July 23, 1993
    Manufacturer
    SIEMENS
    Product Code
    BTX
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE THE ARM BOARD BECAUSE SEPARATED FROM THE O.R. TABLE AND FELL TO THE FLOOR. ARM BOARD APPARED TO BE DEFECTION AT ATTACHMENT SITE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIERIEN MAQUET ARM BOARD BTX SIEMENS 1001-20 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data