BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENTECH MEDICAL SYSTEMS, INC.

    MDR report key: 323917 · Received March 30, 2001

    Report

    Report Number
    323917
    Event Type
    Death
    Date Received
    March 30, 2001
    Date of Event
    March 1, 2001
    Report Date
    March 4, 2001
    Manufacturer
    SENTECH MEDICAL
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT IN BED AT 1AM, CHECKED BY CNA. AT 1:25AM FOUND ON FLOOR. HEAD BETWEEN SIDERAIL AND MATTRESS, REST OF BODY ON FLOOR. BED ALARM DID NOT GO OFF. LIFTED BACK INTO BED WITH 2 CNAS LIFTING BODY AND NURSE MOVING HEAD. CHECKED PULSE AND BREATHING. DID NOT FIND EITHER. BODY WAS STILL WARM AND SKIN PALE. BED ALARM DID SOUND WHEN REPOSITIONING BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14107 SENTECH MEDICAL SYSTEMS, INC. STAGE IV 3000 AIR OVERLAY MATTRESS FNM SENTECH MEDICAL STAGE IV 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death AND SENSOR MAT.| OSPREY-HILLROM BED. BEDCHECK SENSOR CONTROL UNIT