BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROHO LOW PROFILE SINGLE COMPARTMENT CUSHION

    MDR report key: 16855205 · Received May 2, 2023

    Report

    Report Number
    16855205
    Event Type
    Death
    Date Received
    May 2, 2023
    Date of Event
    April 8, 2023
    Report Date
    April 17, 2023
    Manufacturer
    ROHO, INC.
    Product Code
    MOC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EXPIRED RESIDENT FOUND POSITIONED BETWEEN POWER WHEELCHAIR ARMREST AND SEAT. STAFF NEEDED TO REMOVE ARMREST IN ORDER TO RELEASE BODY. EXPIRED RESIDENT FOUND TO HAVE SLID OFF THE RIGHT SIDE OF HIS CHAIR IN THE SPACE BETWEEN THE FLIP UP ARM REST AND HIS WHEELCHAIR SEAT. HIS BOTTOM AND FEET WERE ON THE FLOOR. HIS WHEELCHAIR CUSHION HAD SLID DOWN OVER THE EDGE OF THE POWER WHEELCHAIR AND WAS PRESSING AGAINST HIS NECK AND BACK. HIS RIGHT UPPER EXTREMITY WAS WRAPPED AROUND THE OUTER SIDE OF THE REAR SUPPORT BAR BETWEEN THE RIGHT ARM REST AND BACK REST. HIS CHIN WAS RESTING UPON THE ARM REST. M.E. CONTACTED AND DECLINED JURISDICTION DUE TO BELIEF THAT DEATH WAS LIKELY A NATURAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800289 ROHO LOW PROFILE SINGLE COMPARTMENT CUSHION CUSHION, FLOTATION, THERAPEUTIC MOC ROHO, INC. 1R99LPC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death