BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 1241764 · Received November 19, 2008

    Report

    Report Number
    1831750-2008-00165
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 20, 2008
    Manufacturer
    STRYKER CORP., MEDICAL DIVISION
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT OCCURRED IN ZONE I, AS DEFINED IN THE HBSW GUIDANCE. THE PT WAS NOT TRAPPED IN OR UNDER THE SIDERAIL BUT DUE TO WEAKENED PHYSICAL CONDITION, COULD NOT LIFT HER HEAD UP AND OVER THE SIDERAIL. HER CHIN WAS CAUGHT IN THE HANDGRIP SPACE ON THE INSIDE OF THE SIDERAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELDERLY PT WAS SCOOTING DOWN THE MATTRESS OF HER HOSP BED IN WHAT APPEARED TO BE AN ATTEMPT TO EXIT THE BED. THE BED EXIT ALARM SOUNDED AND THE NURSING STAFF FOUND THE PT WITH HER CHIN STUCK IN AN OPENING IN THE SIDERAIL OF THE BED AND THE REST OF HER BODY OUT OF THE BED WITH HER FEET ON THE FLOOR. THE NURSING STAFF REMOVED THE PT'S CHIN FROM THE SIDERAIL AND RETURNED HER TO THE BED. THE PT REPORTEDLY RECEIVED A SKIN TEAR ACROSS HER CHIN/NECK REQUIRING A DRESSING AND SOME OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED A/C POWERED HOSPITAL BED FNL STRYKER CORP., MEDICAL DIVISION 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention