BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 1591309 · Received January 29, 2010

    Report

    Report Number
    1525712-2010-00010
    Event Type
    Death
    Date Received
    January 29, 2010
    Date of Event
    January 2, 2010
    Report Date
    January 29, 2010
    Manufacturer
    INVACARE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED INFO THAT A USER REPORTEDLY FELL FROM AN INVACARE BED AND SUFFOCATED. INFO IS UNCLEAR AS NO DETAILS HAVE BEEN PROVIDED AT THIS TIME. NO ZONE OF ENTRAPMENT HAS BEEN DETERMINED. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME. MDR FILED BASED ON ALLEGED DEATH.

    Description of Event or Problem · 1

    THE CONSUMER'S GRANDPARENTS ALLEGE THAT HE FELL FROM THE BED AND SUFFOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE BED42-1633

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death| R