BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALYPSO

    MDR report key: 4862292 · Received June 22, 2015

    Report

    Report Number
    3007420694-2015-00124
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARJOHUNTLEIGH HAS RECEIVED A COMPLAINT WHERE IT WAS INDICATED THAT THE PATIENT FELL OFF FROM THE HYGIENIC CHAIR DEVICE ON THE CAREGIVER. IN THE RESULT OF THE FALL THE PATIENT HAS RECEIVED A CONTUSION TO THE SIDES AND LEFT KNEE, THE CAREGIVER HAS RECEIVED A CONTUSION TO THE LEFT CLAVICLE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE WERE ABLE TO ESTABLISH THAT THE COMPLAINT IS CONSIDERED TO BE A SINGLE, ISOLATED EVENT. THE DEVICE WAS EXAMINED BY THE ARJOHUNTEIGH TECHNICIAN VISITING THE SITE AFTER THE EVENT, WHO FOUND THAT THE SAFETY ARM RETAINER WAS BENT, IN THE WAY THAT IN CERTAIN POSITION AND WHEN PULLED IT COULD LET THE ARM TO GET OUT OF THE SOCKET. BASED ON THIS WE CAN CONCLUDE THAT THE DEVICE WAS NOT UP TO THE MANUFACTURER SPECIFICATION AT THE TIME OF THE EVENT. THE SAFETY BELT IS NEEDED FOR EACH USE ACCORDING TO DEVICE LABELLING WAS NOT USED DURING THE INCIDENT. IT WAS ESTABLISHED THAT THE SAFETY BELT WAS NOT USED ON THE PATIENT BECAUSE IT WAS TOO SHORT FOR THE (B)(6) RESIDENT. THIS COULD NOT BE CONFIRMED AS DIMENSIONS OF THE RESIDENT WAS NOT PROVIDED, BUT WHEN LOOKING AT THE MAXIMUM CIRCUMFERENCE, WHICH IS 180 CM, WE COULD ASSUME THAT THE SAFETY BELT FOR CALYPSO WHEN MAXIMALLY STRETCHED CAN EMBRACE EVEN A WIDE RESIDENTS. ADDITIONALLY AS PER INSTRUCTION FOR USE IF THE DEVICE IS NOT ACCURATE FOR THE RESIDENT FOR EXAMPLE WHEN THE SAFETY BELT CANNOT BE USED BECAUSE OF THE SIZE OF THE RESIDENT, WE RECOMMEND TO USE A DIFFERENT DEVICE. THE INSTRUCTION FOR USE DELIVERED WITH CALYPSO DEVICE 004.CD.03 REV. 7 DATED ON SEPTEMBER 2009 (ACTIVE AT THE TIME OF THE MANUFACTURING) SHOWS AND DESCRIBES CORRECT HANDLING DEVICE IN REGARDS TO: USING SAFETY BELTS: "WARNING THE SAFETY BELT MUST BE USED AT ALL TIMES TO MAKE SURE THE RESIDENT REMAINS IN AN UPRIGHT POSITION IN THE MIDDLE OF THE SEAT." POSITIONING PATIENT ON THE CHAIR: "WARNING BEFORE LIFTING CALYPSO OUT OF THE WATER AFTER A BATH, RE-POSITION THE RESIDENT IF NEEDED TO ENSURE THAT THE RESIDENT IS SITTING UPRIGHT IN THE CENTRE OF THE CHAIR!" COMING TO THE SITUATION WHERE THE RESIDENT IS FALLING OUT OF THE HYGIENIC CHAIR, AND TRYING TO RECREATE THE INCIDENT DESCRIPTION, PERFORMING A SIMULATION USING MALFUNCTIONED AND RETURNED PART, WE CONCLUDED THAT THE FOLLOWING SEQUENCE OF THE EVENTS IS NECESSARY TO OCCUR, TO MEET THE EVENT DESCRIPTION AND OUTCOME: THE SAFETY ARM SOCKET IS DEFORMED. THE SAFETY ARM IS NOT ATTACHED WELL TO THE SOCKET BEFORE THE EVENT. THE PIN FROM THE SAFETY ARM IS IN THE POSITION WHERE THE SEAT RETAINER IS BENT AND DEFORMED, AND IS THERE HELD UNDER TENSION. BECAUSE OF THIS BENDING THE PIN COULD GO OUT OF THE RETAINER, ALLOWING THE SAFETY ARM TO BE DETACHED. THE SAFETY ARM WAS NOT IN THE HORIZONTAL POSITION. FOR A PATIENT TO LEAN FORWARD, THE ARM IS PUSHED AND THIS MAKES IT GO OUT OF THE SOCKET, THE PATIENT HAS TO PUSH THEIR BODY WEIGHT ON THE ARM UP TO THE POINT WHERE THE ARM NO LONGER HOLDS IN PLACE, THE PATIENT NEEDS TO BE IN A SITUATION WHERE NO SAFETY BELTS ARE APPLIED, ONLY THEN DOES THE PATIENT FALL DOWN FROM THE CHAIR. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT - RESIDENT FELL OFF THE DEVICE. TO AVOID FALLING, THE CAREGIVER SHALL MAKE SURE THAT THE RESIDENT IS POSITIONED CORRECTLY AND THAT THE SAFETY BELT IS BEING USED, PROPERLY FASTENED AND TIGHTENED. THE SAFETY BELT SHOULD BE USED ALL THE TIME WHEN THE RESIDENT IS BEING MOVED. THE CHAIR SHOULD BE EXAMINED FOR DAMAGE, BEFORE USE. IF ANY OF PARTS ARE DAMAGED, THE DEVICE IS TO BE EXCLUDED FROM USE UNTIL IT IS REPAIRED BY QUALIFIED PERSONNEL. FROM OUR EVALUATION WE CAME TO THE CONCLUSION THAT THE LACK OF USE OF THE SAFETY BELTS, NOT EXCLUDING A MALFUNCTIONING DEVICE FROM USE, NOT MAKING SURE THAT THE SAFETY ARM IS CORRECTLY INSTALLED - IN COMBINATION TOGETHER HAVE CONTRIBUTED TO THE FALL OF THE PATIENT. IN ACCORDANCE TO ABOVE INFORMATION WE CAN STATE THAT THE EVENT WAS CAUSED BY USER ERROR - USER DID NOT FOLLOW IFU. WE CAN STATE THAT THE REPORTED EVENT IS LIKELY RELATED TO USER ERROR AS NO DATES OF LAST TRAINING TO THE CAREGIVER WERE PROVIDED AND DETAILS OF TRAININGS WERE AVAILABLE FOR COMPANY REPRESENTATIVE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE PATIENT WAS SITTING ON THE CHAIR AND WAS LEANING WITH HIS ARMS ON THE ARM OF THE SEAT. THE CAREGIVERS PUT THE CHAIR IN THE UPPER POSITION AND WHEN LIFTING THE PATIENT'S LEG OVER THE SIDE OF THE TUB TO PUT THE PATIENT INTO THE BATH, THE ARM OF THE SEAT HAS PULLED OUT, THE PATIENT TILTED FORWARD AND FELL OFF THE BATH ON THE CAREGIVER. THE PATIENT WAS NOT WEARING THE SAFETY BELT PROVIDED WITH THE DEVICE. THE CAREGIVER RECEIVED A CONTUSION TO THE LEFT CLAVICLE, A PATIENT GOT A CONTUSION TO THE SIDES AND LEFT KNEE. INJURED WENT TO THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402588 CALYPSO FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other