BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHODERM CONVERTIBLE II / ALPHA ACTIVE

    MDR report key: 93485 · Received May 27, 1997

    Report

    Report Number
    93485
    Event Type
    Injury
    Date Received
    May 27, 1997
    Date of Event
    May 14, 1997
    Report Date
    May 15, 1997
    Manufacturer
    WOUND CARE SOLUTIONS
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE AIR MATTRESS HAD DEFLATED ON IT'S OWN WHILE THE PLUG IN PLACE. AS THE RESULT, THE RESIDENT SLID UNDERNEATH THE RAILING OF HER BED. SHE WAS FOUND, HER RT ARM HANGING ON THE RAIL HER HEAD CAUGHT BETWEEN THE MATTRESS AND RAILING, HER FEET ON THE FLOOR. RESIDENT, IS NON-AMBULATORY, UNABLE TO SET UP ON OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHODERM CONVERTIBLE II / ALPHA ACTIVE LOW-AIR LOSS MATTRESS FNM WOUND CARE SOLUTIONS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening