BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENTECH

    MDR report key: 350487 · Received August 28, 2001

    Report

    Report Number
    350487
    Event Type
    Death
    Date Received
    August 28, 2001
    Date of Event
    August 18, 2001
    Report Date
    August 27, 2001
    Manufacturer
    SENTECH MEDICAL SYSTEMS, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT FOUND ON STOMACH, HEAD BETWEEN MATTRESS AND SIDERAIL. MATTRESS WAS DEPRESSED UNDER WEIGHT OF PT. CAUSE OF DEATH DETERMINED BY CORONER TO BE POSITIONAL ASPHYXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39506 SENTECH PRIMARY CARE MATTRESS REPLACEMENT SYSTEM FNM SENTECH MEDICAL SYSTEMS, INC. MDTMSENPCAP *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death VERTICAL SIDING THREE QUARTER BEDSIDE RAIL #2510.