BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA DEVICE NOT SUSPECT. DEVICE IS A SELECTAIR

    MDR report key: 883907 · Received July 20, 2007

    Report

    Report Number
    1419507-2007-00001
    Event Type
    Death
    Date Received
    July 20, 2007
    Date of Event
    May 28, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROHO, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENTIRE SELECTAIR/TRANQUIL CARE SYSTEM WAS FUNCTIONING CORRECTLY. THE USER INSTRUCTIONS WERE NOT FOLLOWED BY THE FACILITY IN THAT THE PROPER ADJUSTMENT OF THE COMFORT LEVEL WAS NOT MADE TO THE CORRESPONDING PT'S WEIGHT AND THE PT'S BODY WAS NOT SUNKEN FORTY TO FIFTY PERCENT INTO THE MATTRESS. THE COMFORT LEVEL AS SET BY THE FACILITY AT THE TIME OF THE INCIDENT WOULD HAVE BEEN CORRECT FOR A PT WEIGHING 300 LBS NOT THE 134.5 LBS WHICH WAS RECORDED IN THE PT'S RECORDS. THIS ALLOWED THE PT'S BODY TO REST ENTIRELY ON THE SURFACE OF THE MATTRESS. THIS PERMITTED THE PT TOTALLY UNENCUMBERED MOVEMENT WHICH IS CONTRARY TO THE INSTRUCTIONS OF THE MANUFACTURER.

    Description of Event or Problem · 1

    FROM THE FACILITY 2007. THE RESIDENT SLID OFF LEFT SIDE OF BED. ELBOW PROTRUDED THROUGH HORIZONTAL BARS OF UPPER SIDE RAIL AND HE WAS WEDGED BETWEEN THE RAIL AND MATTRESS WITH HIS WRIST AGAINST HIS THROAT. CORNER: CAUSE OF DEATH: POSITIONAL ASPHYXIA. MANNER OF DEATH: ACCIDENTAL. FROM MATTRESS PROVIDER FROM APPROX SIX WEEKS EARLIER CONVERSATION W/ THE SNF AND THREE DAYS LATER SITE VISIT: RESIDENT WAS ALERT AND ORIENTED W/ LIMITED MOBILITY. USED RAIL TO ASSIST W/ INDEPENDENT TURNING. AT 10:30PM, APPROX ONE MONTH EARLIER, RESIDENT WAS SEEN BY NURSING ASSISTANT TO BE LYING ON SIDE ASLEEP. SHIFT CHANGE ROUNDS FOUND RESIDENT 11:15-11:20PM OFF SIDE OF BED. BEDDING APPEARED TO HAVE SLID W/PT. PT KNEES ON FLOOR, BUTTOCKS ON HEELS, LEFT ELBOW PROTRUDING THROUGH SIDE RAIL OPENING, LEFT WRIST AGAINST THROAT, HEAD AGAINST MATTRESS, SHOULDER AGAINST FRAME, ENTRAPPED BETWEEN HORIZONTAL OF SIDE RAIL AND MATTRESS. RAIL 1/4-1/3 SIDE RAIL IN UP POSITION. PRELIMINARY AUTOPSY "POSITIONAL ASPHYXIATION." MATTRESS WAS SECURELY ATTACHED TO THE BED FRAME WITH VELCRO STRAPS; NO GAPS ON EITHER SIDE BETWEEN RAILS AND MATTRESS. MATTRESS, HOWEVER, WAS SET AT AN OVER-INFLATED CONDITION; FOR 300LB PERSON NOT 138LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA DEVICE NOT SUSPECT. DEVICE IS A SELECTAIR LOW AIR LOSS MATTRESS REPLACEMENT FNM ROHO, INC. SA2SHORTMATT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 1/4-1/3 SIDE RAILS| RESIDENT ON A JOERNS B-50 MODEL BED W/