BEUDAMED
    FDA Adverse Event Death Summary report: N

    AM FAB 5700 HALF RAIL

    MDR report key: 779789 · Received November 9, 2006

    Report

    Report Number
    1831748-2006-00001
    Event Type
    Death
    Date Received
    November 9, 2006
    Date of Event
    May 8, 2004
    Report Date
    November 1, 2006
    Manufacturer
    AO LIQUIDATION - FORMERLY AM FAB, INC
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN THE POSSESSION OF THE PLAINTIFF (RELATIVE OF DECEASED) IN A SUIT BROUGHT AGAINST THE USER FACILITY, AM FAB, INC., STAN-BARR MEDICAL AND OTHERS. EMPLOYEE FROM AM FAB, INC WAS ALLOWED TO VISUALLY EVALUATE PRODUCT. EMPLOYEE WAS NOT ABLE TO TOUCH DEVICE DURING EVAL. EMPLOYEE NOTED THAT THE SCREWS AND NUTS WITH LOCK WASHER THAT SECURE A CONNECTING PLATE APPEARED TO NOT BE TIGHTENED. ASSEMBLY INSTRUCTIONS INCLUDED WITH THE PRODUCT INDICATE TO TIGHTEN THE CONNECTOR PLATE NUTS. EMPLOYEE COULD NOT DETERMINE IF THE SCREWS AND NUTS WITH LOCK WASHER WERE TIGHTENED BY THE USER FACILITY AT THE TIME OF ASSEMBLY.. BECAUSE THE SCREWS AND NUTS WITH LOCK WASHERS WERE NOT TIGHT, THE SIDE RAILS WERE NOT HELD AT A 90 DEGREE ANGLE TO THE MATTRESS AND WERE SLANTING SLIGHTLY OUTWARD. THIS IS AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    PATIENT BACAME ENTRAPPED BETWEEN THE BED RAIL MANUFACTURED BY AM FAB, INC. AND STEN+BARR SAFETY AIR MATTRESS AMNUFACTURED BY STEN+BARR MEDICAL, INC. PATIENT DIED OF POSITIONAL ASPHYXIA PER MEDICAL EXAMINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AM FAB 5700 HALF RAIL SIDE RAILS (ACCESSORIES FOR BEDS) FNJ AO LIQUIDATION - FORMERLY AM FAB, INC 5700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death STEN+BARR SAFETY AIR MATTRESS