BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTADYNE

    MDR report key: 137635 · Received December 10, 1997

    Report

    Report Number
    137635
    Event Type
    Death
    Date Received
    December 10, 1997
    Date of Event
    November 24, 1997
    Report Date
    December 2, 1997
    Manufacturer
    LUMEX
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LPN WALKING DOWN HALL DOING ROUNDS AND NOTICED RESIDENT WAS NOT IN BED. LPN ENTERED ROOM AND FOUND RESIDENT SITTING ON FLOOR WITH HEAD WEDGED BETWEEN SIDE RAIL AND BED (MATTRESS AND FRAME). RESIDENT WAS WITHOUT PULSE OR RESPIRATIONS. MD NOTIFIED AND PRONOUNCED RESIDENTS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTADYNE AIR BED MATTRESS FNM LUMEX 01-70146 (CONTROL) *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 1. HILL ROM BED 5570