BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS3 BED, HI-LO LOCKOUT 9153654450

    MDR report key: 8622382 · Received May 18, 2019

    Report

    Report Number
    1525712-2019-00014
    Event Type
    Death
    Date Received
    May 18, 2019
    Date of Event
    June 10, 2018
    Report Date
    May 8, 2019
    Manufacturer
    INVACARE CORPORATION
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE IHCS3HLOCK-C WAS OBTAINED BY INVACARE. 15GFT000763 INDICATES THAT THIS BED WAS MANUFACTURED IN (B)(6) 2015 MAKING THE BED 3 YEARS 11 MONTHS IN AGE AT THE TIME OF THE EVENT.

    Description of Event or Problem · 0

    BED ENTRAPMENT INFORMATION RECEIVED FROM HEALTH CANADA: HEALTH CANADA WAS MADE AWARE OF A DEATH THAT OCCURRED AT MAPLE MANOR IN TILLSONBURG, ON, ON (B)(6) 2018. PATIENT WAS FOUND TO HAVE HIS TORSO AND LEGS ON THE GROUND WITH HIS HEAD WEDGED BY THE RAILING. THE CAUSE OF DEATH PROVIDED RECENTLY WAS DETERMINED TO BE POSITIONAL ASPHYXIA.

    Additional Manufacturer Narrative · 1

    THE ADMINISTRATOR AT (B)(4), CONFIRMED THAT THE CS3 BED WAS EQUIPPED WITH AN INVACARE THINKSOFT POSITIONING DEVICE AND A NON-INVACARE WATERLOO 200 TWIN MATTRESS. SHE DID NOT KNOW IF THIS WAS AN AIR, INNERSPRING OR FOAM MATTRESS & THE DIMENSIONS WERE ALSO UNKNOWN. INVACARE HIGHLY RECOMMENDS THAT AN INVACARE BRAND MATTRESS THAT CONFORMS TO THE FOLLOWING DIMENSIONS IS USED FOR THE CS3 BED: LENGTH, 76" OR 80" (1930 MM OR 2032 MM), WIDTH, 36" (901 MM) AND DEPTH 6" (152 MM). THE BED WAS POSITIONED AT THE LOWEST SETTING, WHICH FOR THE CS3 BED IS 8.5 INCHES AND THE ADMINISTRATOR BELIEVES THAT THE HEAD & FOOT SECTIONS OF THE BED WERE FLAT, NOT ELEVATED. THE POSITIONING DEVICE WAS IN THE UP POSITION. THERE WAS NO MALFUNCTION RELATING TO THE BED OR RAIL PER THE FACILITY, THEREFORE, THE BED WAS PUT BACK INTO SERVICE ON A DIFFERENT PATIENT WITH NO RAILS & A DIFFERENT MATTRESS. INVACARE HAD NO PREVIOUS COMPLAINTS INVOLVING ENTRAPMENT ASSOCIATED WITH THE CS3 BED OVER THE PAST 4 YEARS, THERE WERE NO TRENDING TRIGGERS RELATING TO ENTRAPMENT MET WITHIN THAT TIME. THE IHCS3 BED WAS CLASSIFIED TO IEC 60601-2-38, PARTICULAR REQUIREMENTS FOR THE SAFETY OF ELECTRICALLY OPERATED HOSPITAL BEDS (PROVIDES SIZING INDICATIONS FOR FREQUENT ENTRAPMENT ZONES) AND HAS BEEN TESTED TO MEET FDA GUIDANCE DOCUMENT ¿HOSPITAL BED DIMENSIONAL AND ASSESSMENT GUIDANCE TO REDUCE ENTRAPMENT¿ WHICH PROVIDES DIMENSIONAL INDICATIONS FOR FREQUENT ENTRAPMENT ZONES AND TEST METHODS FOR PRODUCT EVALUATION. THE INVACARE OWNERS MANUAL PROVIDES ADDITIONAL WARNINGS AND CONSIDERATION FOR ENTRAPMENT ASSOCIATED WITH THE BED AND PRODUCT CONFIGURATION.

    Description of Event or Problem · 1

    THE PATIENT WHO WAS OCCUPYING AN IHCS3HLOCK-C, CS3 BED, HI-LO LOCKOUT WITH THE IHCSTSPD-QSP, THINKSOFT POSITIONING DEVICE ATTACHED, WAS FOUND TO HAVE HIS TORSO AND LEGS ON THE GROUND WITH HIS HEAD WEDGED BY THE RAILING. THE CAUSE OF DEATH PROVIDED WAS DETERMINED TO BE POSITIONAL ASPHYXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415767 CS3 BED, HI-LO LOCKOUT 9153654450 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE CORPORATION NA:IHCS3HLOCK-C

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death