BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPENCO

    MDR report key: 169240 · Received May 23, 1998

    Report

    Report Number
    169240
    Event Type
    Death
    Date Received
    May 23, 1998
    Date of Event
    May 8, 1998
    Report Date
    May 22, 1998
    Manufacturer
    SPENCO MEDICAL CORP.
    Product Code
    FMP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS NON-AMBULATORY RESIDENT HAD A HISTORY OF FREQUENTLY CLIMBING AND FALLING OUT OF BED. THE ATTENDING PHYSICIAN HAD ORDERED THAT THE RESIDENT BE ON A FLOOR/PLATFORM BED WHICH IS A LOW BED ON WHICH A REGULAR MATTRESS WAS PLACED. BESIDE THE BED, ANOTHER MATTRESS WAS PLACED ON THE FLOOR TO BREAK FALL WHEN RESIDENT WOULD ROLL OUT OF BED. IN ADDITION, NURSING STAFF PLACED A SPENCO MATTRESS AS AN OVERLAY ON TOP OF THE MATTRESS ON THE FLOOR. ON 05-08-98 THE RESIDENT WAS FOUND UNRESPONSIVE ON THE FLOOR MATTRESS FACE DOWN IN THE SPENCO MATTRESS. CPR WAS INITIATED AND 911 WAS CALLED AND HE WAS TRANSPORTED TO HOSP. HE DIED AT HOSP ON 5-23-98. THE SOFT, CUSHIONY SPENCO MATTRESS MAY HAVE CONTRIBUTED TO THE ADVERSE OUTCOME FOR THE RESIDENT (IE SUFFOCATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPENCO SILICONE BED PAD FMP SPENCO MEDICAL CORP. NONE *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L