BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALYPSO

    MDR report key: 3201521 · Received June 27, 2013

    Report

    Report Number
    9611530-2013-00058
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). IT WAS REPORTED TO US THAT DURING BATHING TREATMENT USING ARJOHUNTLEIGH CALYPSO BATH CHAIR, THE RESIDENT ALMOST SLIPPED OFF THE CHAIR. NO INJURIES WERE SUSTAINED. THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED. WHEN REVIEWING REPORTABLE EVENTS LESS THAN TWO CASES PER YEAR WITH A SIMILAR FAULT DESCRIPTION (PATIENT SLIP/FALL FROM CALYPSO DEVICE) WAS FOUND. (B)(4). WE WERE NOT ABLE TO FIND A DEFICIENCY WITH THE DEVICE. THIS IMPLIES THAT THE LIFTING SYSTEM WAS UP TO SPECIFICATION WHEN THE EVENT TOOK PLACE. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. THE MOST RELEVANT USE ERROR BEING A FAILURE TO PROPERLY POSITION THE PATIENT ON THE DEVICE IN A COMBINATION WITH IMPROPER USE THE SAFETY BELT: IT IS STATED IN THE INSTRUCTIONS FOR USE 904.CD.03 REV.2): 'WARNING! MAKE SURE THE PATIENT IS SITTING STRAIGHT UPRIGHT IN THE MIDDLE OF THE SEAT' THE SAFETY BELT PART OF THE IFU STATES: 'THE SAFETY BELT SHOULD BE USED ALL THE TIME WHEN THE RESIDENT IS MOVED.' PLEASE BE AWARE THAT THE DEVICE IS 17 YEARS OLD AND IT'S PASSED THE INTENDED LIFETIME ACCORDING TO THE IFU: 'THE USEFUL LIFE OF THIS EQUIPMENT, UNLESS OTHERWISE STATED, IS TEN (10) YEARS, SUBJECT TO REQUIRED PREVENTATIVE MAINTENANCE AS SPECIFIED IN ARJO'S OPERATING AND DAILY MAINTENANCE INSTRUCTION AND SPACE PARTS LIST.' WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR AS THE RECEIVED INFO AND OUR EVAL AS DESCRIBED ABOVE ARE SHOWING THAT IF THE SAFETY WARNINGS PRESENT IN THE INSTRUCTIONS FOR USE TO CORRECTLY USE THE DEVICE ARE FOLLOWED, IT APPEARS VERY UNLIKELY THAT THERE WILL BE ANY PATIENT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294338 CALYPSO NONE FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1