BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPIRIT PLUS

    MDR report key: 4491279 · Received January 28, 2015

    Report

    Report Number
    3006433555-2015-00001
    Event Type
    Death
    Date Received
    January 28, 2015
    Date of Event
    January 1, 2015
    Report Date
    January 28, 2015
    Manufacturer
    CHG HOSPITAL BEDS INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFO WAS REPORTED BY THE USER FACILITY: THE BED WAS IN THE LOW, FLAT POSITION AT THE TIME OF THE EVENT.; ALL FOUR SIDERAILS WERE IN THE RAISED POSITION AT THE TIME OF THE EVENT.; APPROX 1 HOUR HAD ELAPSED BETWEEN THE LAST PT CHECK AND DISCOVERY. THE MFR VISITED THE FACILITY AND EVALUATED THE UNIT INVOLVED IN THE REPORTED INCIDENT. THE RAILS LATCHED AND FUNCTIONED PROPERLY, AND NO ALIGNMENT ISSUES WERE OBSERVED. THE CYLINDER TOOL SPECIFIED IN IEC (B)(4) WAS USED TO ASSESS THE GAP BETWEEN THE RAILS. THE 60MM CYLINDER TOOL DID NOT ENTER THE GAP BETWEEN THE RAILS AND THEREFORE MET THE REQUIREMENT OF THE STANDARD. NO MALFUNCTION OR DEFECT WAS FOUND, AND NO CORRECTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT A NURSE WENT TO THE PT ROOM TO CHECK ON THE PT. THE PT WAS ALLEGEDLY FOUND DECEASED, KNEELING ON THE FLOOR, WITH HIS HEAD BETWEEN THE LEFT HEADEND AND FOOTEND SIDERAILS. THE USER FACILITY FURTHER REPORTED THAT THE PT, WHO WAS ADMITTED FOR "BEHAVIORAL ISSUES", WAS AMBULATORY AND WAS GIVEN THE FREEDOM TO GET OUT OF BED AND WALK AROUND. THE UNIT INVOLVED IN THE REPORTER INCIDENT WAS EVALUATED BY THE MFR, AND NO MALFUNCTIONS OR DEFECTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64687 SPIRIT PLUS AC-POWERED ADJUSTABLE HOSPITAL FNL CHG HOSPITAL BEDS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death