BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED CHECK

    MDR report key: 1933744 · Received December 20, 2010

    Report

    Report Number
    1929691-2010-00003
    Event Type
    Death
    Date Received
    December 20, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION
    Product Code
    KMI
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12-9-2010: THE EQUIPMENT WAS RETURNED BY (B)(6) AND WAS FULLY EVALUATED. THE BED CHECK CLASSIC-CHECK MODEL 72021 AND BED SENSORMAT 74011 TESTED ACCORDING TO MANUFACTURER SPECIFICATION. THE RESIDENT WAS CAUGHT BETWEEN THE BED RAIL AND BED MATTRESS WHICH DID NOT ALLOW FOR A FULL EXIT. AS REPORTED BY THE FACILITY THE RESIDENT REMAINED ON THE MAT, THEREFORE THE MAT DID NOT ALARM. UPON REMOVING THE RESIDENT FROM THE MAT, THE FACILITY REPORTED THAT THE BED CHECK MONITOR AND PAD IMMEDIATELY SIGNALED AN ALARM VERIFYING THE PRODUCT WAS FULLY OPERATIONAL. ADDITIONAL MODEL NUMBER: 74011, LOT# A0210 (74011).

    Description of Event or Problem · 1

    RESIDENT WAS FOUND WITH LOWER BODY ON FLOOR AND UPPER BODY LEANING AGAINST BED. RESIDENT'S HEAD WAS ON BED ON LEFT SIDE IN BETWEEN MATTRESS AND SIDE RAIL. BED ALARM DID NOT SOUND AS HEAD WAS ON THE BED ALARM SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED CHECK CLASSIC-CHECK AND BED SENSORMAT KMI STANLEY SECURITY SOLUTIONS, INC., SENIOR TECHNOLOGIES DIVISION 72021

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death