BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALYPSO

    MDR report key: 6063083 · Received October 28, 2016

    Report

    Report Number
    3007420694-2016-00225
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O.(REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB LTD (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O.(REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB LTD (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT AFTER BEING LIFTED FROM TUB, THE RESIDENT WAS LEFT UNATTENDED ON THE CALYPSO HYGIENE CHAIR WHILE THE CAREGIVER WAS TAKING THE TOWEL. AT THIS MOMENT THE RESIDENT FELL TOGETHER WITH THE CHAIR. THE DEVICE WAS EXAMINED BY ARJOHUNTLEIGH REPRESENTATIVE AND WAS DESCRIBED TO BE IN GOOD CONDITION, ALL FUNCTIONS WORKING AS INTENDED, SAFETY BELT WAS WORN BUT STILL IN USE. THE LIFT WAS UP TO MANUFACTURER'S SPECIFICATION. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, A LIMITED NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (CALYPSO TIPPING) WERE FOUND. THE COMPLAINT RATIO WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW. THE OPERATING AND PRODUCT CARE INSTRUCTIONS (OPCI) CLEARLY STATES HOW TO OPERATE THE DEVICE PROPERLY AND GIVES NUMBER OF PRECAUTIONS TO AVOID HAZARDOUS SITUATIONS. "THE CALYPSO MUST BE USED BY APPROPRIATELY TRAINED CAREGIVERS IN ACCORDANCE WITH THE DIRECTIONS OUTLINED IN THE OPERATING AND PRODUCT CARE INSTRUCTIONS." ACCORDING TO PROVIDED INFORMATION, THE RESIDENT WAS REPORTED TO BE CLASSIFIED AS DORIS IN THE MOBILITY GALLERY, WHICH MEANS THAT WAS ABLE TO SIT ONLY IF WELL SUPPORTED. THIS IS CONTRARY TO THE OPCI: "CAREGIVERS SHOULD ASSESS EACH RESIDENT ACCORDING TO THE FOLLOWING CRITERIA PRIOR TO USE: THE RESIDENT SHOULD BE ACTIVE OR SEMI-ACTIVE (I.E. ABLE TO SIT UPRIGHT UNSUPPORTED ON THE SIDE OF A BED OR TOILET). THE RESIDENT SHOULD UNDERSTAND AND RESPOND TO INSTRUCTIONS TO STAY SEATED IN AN UPRIGHT POSITION. IF A RESIDENT DOES NOT MEET THESE CRITERIA AN ALTERNATIVE LIFT SHALL BE USED." IT CAN BE CONCLUDED THAT CALYPSO COULD NOT HAVE BEEN THE RIGHT DEVICE FOR THIS PARTICULAR PATIENT. MOREOVER, THE CAREGIVER LEFT THE RESIDENT UNATTENDED, WHICH IS ALSO NOT IN LINE WITH THE OPCI: "WARNING: ALWAYS PAY CLOSE ATTENDANCE TO THE RESIDENT DURING TRANSFERRING, TRANSPORTING AND BATHING." IT WAS STATED THAT THE RESIDENT WAS NOT WEARING SAFETY BELTS, WHICH IS ANOTHER ACTION CONTRARY TO OPERATING AND PRODUCT CARE INSTRUCTIONS: "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. THE SAFETY BELT MUST BE ATTACHED TO THE SEAT OF THE CALYPSO ON THE SAME SIDE AS THE BACKREST AND SECURELY FASTENED WITH THE BUCKLE." THEREFORE IT APPEARS THAT A USER ERROR AND UNFORTUNATE CIRCUMSTANCES CAUSED THE EVENT, THE MOST RELEVANT USER ERRORS BEING: WRONG EVALUATION OF THE RESIDENT FOR USING CALYPSO CHAIR, NOT PAYING ATTENTION OF THE PATIENT POSITIONING, NOT APPLYING THE SAFETY BELTS. LOOKING AT THE INCIDENT SCENARIO IT HAS BEEN ESTABLISHED THAT CALYPSO HYGIENE CHAIR WAS BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT AND IN THAT WAY CONTRIBUTED TO THE EVENT. THERE WAS NO DEVICE DEFICIENCY FOUND AND FROM THAT PERSPECTIVE THE SYSTEM WAS UP TO SPECIFICATION AT THE TIME OF THE INCIDENT. WHEN THE OPCI WOULD HAVE BEEN FOLLOWED AND THE PROFESSIONAL ASSESSMENT OF THE PATIENT WOULD BE PROVIDED, IT IS HIGHLY PROBABLE THAT THIS EVENT WOULD NOT HAVE HAPPENED.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT FOR CALYPSO CHAIR. IT WAS REPORTED THAT AFTER ASSISTED BATH, THE PATIENT WAS MOVED OUTSIDE THE TUB. THE CAREGIVER LEFT HER UNATTENDED TO TAKE A TOWEL. THE PATIENT FELL TO THE GROUND TOGETHER WITH THE CHAIR WHICH FELL ON HIM. IT WAS POINTED OUT THAT THE PATIENT HAD NO SAFETY BELT. AS A RESULT, THE PATIENT SUFFERED CRANIAL TRAUMA AND BROKEN SEPTUM AND WAS TRANSFERRED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715364 CALYPSO LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB CDB7001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization