BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR CARE CUSHION

    MDR report key: 3330634 · Received August 29, 2013

    Report

    Report Number
    1000381138-2013-00005
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    KIC
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, A BRANCH OF ARJO LTD (B)(4) ON BEHALF OF THE IMPORTER (B)(4). 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 THAT CONTRIBUTE TO THE EVENT. ARJOHUNTLEIGH HAVE BEEN INFORMED THAT A RESIDENT HAD DIFFICULTIES REMAINING UPRIGHT AND EVENTUALLY FELL FROM AN AIR CARE SEAT CUSHION INSTALLED ON THEIR CHAIR. REVIEW OF SIMILAR REPORTABLE EVENTS AS WELL AS STANDARD COMPLAINTS FOR AIR CARE CUSHION, REVEALED THAT THERE ARE NO SIMILAR CASES RECORDED WITH SIMILAR FAILURE MODE. THE INCIDENT IS THE FIRST ONE REPORTED TO US ASSOCIATED WITH THE PT FALL FROM THE CHAIR WHILE USING AIR CARE SEAT CUSHION. THE SEAT CUSHION WAS BEING USED AT THE TIME WHEN THE INCIDENT OCCURRED AND IT CONTRIBUTED TO THE EVENT SINCE THE RESIDENT SLIPPED OFF THE CUSHION ONTO THE FLOOR. THE SEAT CUSHION WAS INSPECTED BY AN ARJOHUNTLEIGH REP WHO CONFIRMED THAT WHEN THE EVENT OCCURRED THE DEVICE WAS WORKING AS INTENDED AND FOUND TO BE TO SPECIFICATION. IT WAS ALSO FOUND THAT THE GENERAL CONDITION OF THE DEVICE WAS GOOD, WITH ONLY MINOR WEAR AND TEAR MARKS. AFTER THE INCIDENT THE CUSHION WAS TESTED, HOWEVER, NO FAULTS WERE FOUND. ALSO, WE HAVE NOT BEEN ABLE TO FIND AND CONFIRM ANY CONTRIBUTING MFG ANOMALIES. THE DYNAMIC ACTION OF THE CUSHION SYSTEM IS PROVIDED BY THE PEGASUS AIR CARE POWER UNIT AND WILL REGULARLY REDUCE PRESSURE ON THE VULNERABLE PRESSURE AREAS WITH THE RESULTING FLOW OF BLOOD AND LYMPH PROVIDING PROTECTION AGAINST THE TRAUMA OF PRESSURE ULCERS. THE OPTIMAL PERFORMANCE OF THE DEVICE DEPENDS ON ATTAINING A GOOD SEATED POSITION - CHAIR HEIGHT AND POSTURE. BASED ON COLLECTED INFO TO DATE IT APPEARS THAT THE INCIDENT - RESIDENT FELL FROM THE CHAIR TWICE, WAS A RESULT OF THE IMPROPER ADJUSTMENT OF THE CHAIR HEIGHT. FROM THE INCIDENT DESCRIPTION IT APPEARS THAT THE EXTRA HEIGHT DIFFERENCE (125 MM) OF CORRECTLY INFLATED CUSHION HAS CAUSED THE RESIDENT WAS NOT ABLE TO SUPPORT HERSELF PROPERLY AND WITH EACH CYCLE SLOWLY SLIPPED OFF THE CHAIR. IT APPEARS A CORRECT EVAL OF THE SITUATION WHICH WOULD HAVE COME FROM FOLLOWING THE PROCEDURES IN THE DEVICE LABELING WOULD HAVE ADDITIONALLY PRECLUDED THE EVENT FROM OCCURRING. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE USER ERROR AS THE PARTS OF THE IFU MENTIONED ABOVE ARE SHOWING THAT IF IFU SAFETY WARNINGS ARE FOLLOWED AND IF RESIDENT WOULD BE CORRECTLY POSITIONED THIS WOULD NOT LEAD TO PT SLIPPED OFF THE SEAT CUSHION. WE TAKE ALL ISSUES OF THIS NATURE SERIOUSLY AND WILL CONTINUE TO MONITOR ANY FUTURE TRENDS THAT MAY ARISE FROM THE USE OF OUR PRODUCTS, HOWEVER, BASED ON THE INFO PROVIDED, WE BELIEVE THE CONTRIBUTING FACTOR OF PT FALL FROM THE CHAIR WAS THE FAILURE TO ADEQUATELY ADJUST THE CHAIR HEIGHT TO PROVIDE STABLE AND CORRECT RESIDENT POSITION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424695 AIR CARE CUSHION NONE KIC ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB 2205

    Patients

    Seq Age Sex Outcome Treatment
    1