BEUDAMED
    FDA Adverse Event Death Summary report: N

    OSPREY BED

    MDR report key: 1609742 · Received February 8, 2010

    Report

    Report Number
    1824206-2010-01983
    Event Type
    Death
    Date Received
    February 8, 2010
    Date of Event
    September 7, 2007
    Report Date
    January 14, 2010
    Manufacturer
    HILL-ROM RITTER
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADMINISTRATOR AT THE FACILITY STATED THAT THE ALLEGED INCIDENT HAPPENED A YEAR BEFORE HE WAS EMPLOYED AT THE FACILITY. THE PATIENT BECAME ENTRAPPED IN ZONE 4 OF THE P871 BED, BETWEEN THE MATTRESS AND THE END OF THE HEAD SIDERAIL. THE BEDS WERE SHIPPED WITH HEAD-END 1/2 LENGTH SIDERAILS ONLY. THE ADMINISTRATOR STATED THAT THE FACILITY REMOVED ALL OF THE SIDERAILS FROM THE BEDS AFTER THE INCIDENT. THE ADMINISTRATOR STATED THAT THE BED HAD A (B) (4) LS6000 LOW-AIR-LOSS MATTRESS AT THE TIME OF THE INCIDENT AND THAT WAS THE ONLY MATTRESS ON THE BED AT THE TIME. THE (B) (4) LS6000 MATTRESS IS NOT AN APPROVED HILL-ROM MATTRESS.

    Description of Event or Problem · 1

    A FEMALE IN A NURSING HOME WITH HISTORY OF FALLS FROM BED. THERE WAS A LOW FLOW AIR MATTRESS OF UNKNOWN TYPE ON A HILL-ROM OSPREY P871 ELECTRIC LONG TERM CARE BED. THE BED CLIP ALARM WAS NOT FUNCTIONING. THE PT SLIPPED BETWEEN THE RAIL AND THE MATTRESS AND WAS FOUND SITTING ON FLOOR. HEAD AND NECK IN RAIL, SITTING UP. AUTOPSY FOUND THAT SHE DIED OF MECHANICAL POSITIONAL ASPHYXIA. THE LOW FLOW AIR-MATTRESS IS NOT IDENTIFIED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSPREY BED AC POWERED HOSPITAL BED FNL HILL-ROM RITTER 871

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death