BEUDAMED
    FDA Adverse Event Death Summary report: N

    3000 ELECTRIC - 78"

    MDR report key: 3083312 · Received April 29, 2013

    Report

    Report Number
    0001831750-2013-03853
    Event Type
    Death
    Date Received
    April 29, 2013
    Date of Event
    July 27, 2012
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP IS BEING SUBMITTED WITH ADDITIONAL MODEL INFORMATION, SERIAL NUMBER, AND MANUFACTURE DATE. THE INFORMATION WAS INITIALLY NOT PROVIDED BY THE CUSTOMER, BUT WAS SUBSEQUENTLY RECEIVED. BED EVALUATION COULD NOT BE PERFORMED, SINCE THE EVENT OCCURRED SEVERAL MONTHS AGO AND WAS ONLY RECENTLY REPORTED BY THE CUSTOMER. BED WAS ALREADY PLACED BACK INTO SERVICE

    Additional Manufacturer Narrative · 1

    DEVICE INVOLVED IN EVENT NOT IDENTIFIED BY FACILITY; THEREFORE IT IS UNKNOWN AT THIS TIME IF DEVICE EVALUATION WILL BE POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE RESIDENT WAS ALLEGEDLY FOUND DECEASED, HEAD TRAPPED BETWEEN THE SIDERAIL AND THE FOOT END OF THE BED. IT WAS ADDITIONALLY REPORTED THAT THE RESIDENT SUFFERED FROM SEVERE PARKINSONS, AND ALWAYS REFUSED RESTRAINTS EXCEPT FOR SIDERAILS. ALLEGEDLY, THE RESIDENT WAS SETTLED IN BED WITH SIDERAILS UP AT 21:00 HOURS AND WHEN THE STAFF MADE THEIR ROUNDS AS SCHEDULED AT 22:00 HOURS, THEY FOUND THE RESIDENT STUCK BETWEEN THE FOOT AND THE SIDERAIL, WITH HER NECK LEANING ON THE METAL BAR THAT PIVOTS THE SIDERAIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE RESIDENT WAS ALLEGEDLY FOUND DECEASED, HEAD TRAPPED BETWEEN THE SIDERAIL AND THE FOOT END OF THE BED. IT WAS ADDITIONALLY REPORTED THAT THE RESIDENT SUFFERED FROM SEVERE PARKINSONS, AND ALWAYS REFUSED RESTRAINTS EXCEPT FOR SIDERAILS. ALLEGEDLY, THE RESIDENT WAS SETTLED IN BED WITH SIDERAILS UP AT 21:00 HOURS AND WHEN THE STAFF MADE THEIR ROUNDS AS SCHEDULED AT 22:00 HOURS, THEY FOUND THE RESIDENT STUCK BETWEEN THE FOOT AND THE SIDERAIL, WITH HER NECK LEANING ON THE METAL BAR THAT PIVOTS THE SIDERAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185487 3000 ELECTRIC - 78" BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death