BEUDAMED
    FDA Adverse Event Death Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2510410 · Received March 30, 2012

    Report

    Report Number
    1525712-2012-00380
    Event Type
    Death
    Date Received
    March 30, 2012
    Date of Event
    March 4, 2012
    Report Date
    March 23, 2012
    Manufacturer
    UNKNOWN
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL IH720-3M, SERIAL NUMBER/DATE CODE IS UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1023891 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE PATIENT WAS PETITE IN STATURE AND WEIGHED APPROXIMATELY (B)(6) THE PATIENT AGE AND HEIGHT ARE UNKNOWN. THE PATIENT HAD A PREEXISTING CONDITION OF ALZHEIMER'S. HER STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE PATIENT'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. INVACARE RECEIVED A CALL FROM THE ADMINISTRATOR OF (B)(6) WHO STATED THAT THE BED DID NOT PLAY A MAJOR ROLE IN THE ALLEGED ENTRAPMENT INCIDENT. HE STATED THAT THE INCIDENT WAS REVIEWED BY THE MEDICAL DIRECTOR AND THE PATIENT'S PHYSICIAN WHO BOTH STATED THAT THE PATIENT WAS ACTIVELY DYING. THE PATIENT HAD A NECK BRACE ON AT THE TIME OF THE INCIDENT. THE PATIENT'S BODY WAS FOUND ON THE FLOOR. HER FACE WAS IN THE DIRECTION OF THE HEADBOARD. HER HEAD WAS FOUND BETWEEN THE MATTRESS AND THE RAIL. THIS IS CONSISTENT WITH (B)(4) OF THE FDA GUIDANCE ON BED ENTRAPMENT. THE ADMINISTRATOR DID NOT HAVE THE SERIAL NUMBER OF THE BED OR THE DATE CODE OF THE QUARTER RAIL. HE WILL BE GETTING THIS INFORMATION. IN ADDITION, HE CONFIRMED THAT THE MATTRESS WAS NOT INVACARE. IT WAS A LOW AIR LOSS MATTRESS. THE MATTRESS WAS SHIFTED AT THE TIME OF THE INCIDENT. THE PATIENT DID NOT MOVE MUCH IN THE LAST 17 DAYS. SHE WAS DIAGNOSED WITH ALZHEIMER'S AND THAT IS MORE THAN LIKELY THE CAUSE OF DEATH. AN AUTOPSY WAS NOT PERFORMED. THE ADMINISTRATOR INDICATED THAT THEY TRIED TO RECREATE THE INCIDENT AND FOUND THAT THE BRACE DID NOT PLAY A FACTOR OR CREATE RESISTANCE IN REMOVING ONE'S SELF FROM THE RAIL OR FROM THAT POSITION. THE BED WAS EVALUATED AND PUT BACK INTO CIRCULATION. THE ADMINISTRATOR STATED THAT THERE IS DOCUMENTED SUPPORT THAT THE CAUSE OF THE INCIDENT WAS NOT DUE TO THE PRODUCT. THERE WAS NO MALFUNCTION OF THE PRODUCT. THE ADMINISTRATOR REQUESTED INFORMATION ON THE QUARTER RAILS AND IF BOTH SHOULD BE ELEVATED. HE OBSERVED THAT IF ONE SIDE WAS ELEVATED AND THE OTHER WAS NOT AND THE BED WAS INCLINED THEN THE NON-INVACARE MATTRESS WOULD SHIFT.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED POSSIBLE RAIL ENTRAPMENT. DEATH ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL UNKNOWN IH7203M

    Patients

    Seq Age Sex Outcome Treatment
    1 Death