BEUDAMED
    FDA Adverse Event Death Summary report: N

    1824206-2001-00011

    MDR report key: 323413 · Received March 30, 2001

    Report

    Report Number
    1824206-2001-00011
    Event Type
    Death
    Date Received
    March 30, 2001
    Date of Event
    October 19, 2000
    Manufacturer
    REMANUFACTURED BY MEDRECO INC.
    Product Code
    FNJ
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED FROM A FDA INSPECTOR THROUGH A USER REPORT # 3357690000-2000-0001 ON 3/20/2001, WHICH ALLEGED A HILL-ROM BED WAS INVOLVED WITH AN ENTRAPMENT ISSUE THAT RESULTED IN A DEATH. THE USER REPORT EVENT DESCRIPTION READ AS FOLLOWS: RESIDENT FOUND IN KNEELING POSITION AT SIDE OF BED. RESIDENT'S HEAD BETWEEN MATTRESS AND BOTTOM PORTION OF SIDE RAIL. NO SPONTANEOUS RESPIRATIONS/PULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14125 FNJ REMANUFACTURED BY MEDRECO INC.

    Patients

    Seq Age Sex Outcome Treatment
    1