BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALENTI

    MDR report key: 6002864 · Received October 6, 2016

    Report

    Report Number
    3007420694-2016-00207
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    June 12, 2016
    Report Date
    September 6, 2016
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). 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). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT AFTER BEING LIFTED FROM TUB, THE RESIDENT LEANED FORWARD WHILE STILL SITTING ON THE LIFT, SECURED WITH THE SAFETY BELT. THE LIFT TIPPED OVER TOGETHER WITH THE PATIENT. THERE WAS ONLY ONE STAFF MEMBER -WHO WAS A SUMMER STUDENT- PRESENT AT TIME OF INJURY. THE DEVICE WAS EXAMINED BY AN ARJOHUNTLEIGH REPRESENTATIVE AFTER THE INCIDENT. AT THE MOMENT OF THE EVENT IT WAS UP TO MANUFACTURER'S SPECIFICATION EXCEPT FROM THE CRACKED COVER, WHICH IS NOT CONSIDERED TO HAVE HAD INFLUENCE ON THE EVENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, A LIMITED NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (ALENTI TIPPING) WERE FOUND. THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE IS CURRENTLY CONSIDERED TO BE LOW AND DECREASING. THE COMPLAINT RATIO WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW. IT HAS TO BE POINTED THAT THE ALENTI DESIGN IS ATTESTED AND FULFILLS THE REQUIREMENTS OF THE STABILITY AND DOES NOT TIP WITHIN NORMAL AND ON-LABEL USE DUE TO A PERSON LEANING SLIGHTLY OVER. WITH REFERENCE TO INTERNAL TESTS AND IN ACCORDANCE TO INTERNATIONAL STANDARDS, THE ALENTI IS CAPABLE OF MAINTAINING EQUILIBRIUM AT ANGLES FAR BEYOND THE MAXIMUM ENVIRONMENT SPECIFICATIONS, AT FULL SWL (SAFE WORKING LOAD), AND IN ITS HIGHEST STROKE POSITION. THE TEST WAS CONFIRMED BY TUV IN 2004. THE INSTRUCTIONS FOR USE, WHICH IS DISTRIBUTED WITH EVERY DEVICE, CLEARLY STATES HOW TO OPERATE IT PROPERLY AND GIVES NUMBER OF PRECAUTIONS TO AVOID HAZARDOUS SITUATIONS. THE INSTRUCTION HOW THE RESIDENT SHOULD BE POSITIONED IS SUPPORTED BY THE PICTURES. "ALENTI MUST BE USED BY APPROPRIATELY TRAINED CAREGIVERS WITH ADEQUATE KNOWLEDGE OF THE CARE ENVIRONMENT, ITS COMMON PRACTICES AND PROCEDURES, AND IN ACCORDANCE WITH THE GUIDELINES IN THE OPERATING AND PRODUCT CARE INSTRUCTIONS." "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 SELFSUPPORTED 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." "TO AVOID THE POSSIBILITY OF INJURY ALWAYS ENSURE THAT: THE EQUIPMENT IS USED BY APPROPRIATE TRAINED STAFF. BEFORE LIFTING ALENTI OUT OF THE WATER AFTER THE BATH, REPOSITION THE RESIDENT IF NEEDED TO ENSURE THE RESIDENT IS SEATED UPRIGHT WITH HIS/HER BUTTOCKS AT THE BACK OF THE SEAT, HIS/HER BACK AGAINST THE BACKREST AND HIS/HER HANDS ON THE HANDREST." "WARNING: ALWAYS PAY CLOSE ATTENDANCE TO THE RESIDENT DURING TRANSFERRING, TRANSPORTING AND BATHING." "WARNING: BEFORE LIFTING ALENTI 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." FROM THE DESCRIPTION OF THE EVENT IT APPEARS THAT THERE WAS NO RELEVANT TECHNICAL DEFICIENCY WITH THE DEVICE AND IT WAS DUE TO A NUMBER OF USER ERRORS AND UNFORTUNATE CONDITIONS CONTRIBUTED TO THE EVENT. THE MOST IMPORTANT COULD BE POINTED: OPERATING THE LIFT BY UNTRAINED CAREGIVER, WHO WAS A SUMMER STUDENT, LEANING OF THE RESIDENT FORWARD, NOT PAYING ATTENTION IF THE PATIENT WAS WELL POSITIONED. LOOKING AT THE INCIDENT SCENARIO IT HAS BEEN ESTABLISHED THAT THE HYGIENE CHAIR WAS BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT IN SUCH A WAY THAT WAY CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT AFTER BEING LIFTED FROM TUB THE RESIDENT LEANED FORWARD WHILE STILL SITTING ON THE LIFT, SECURED WITH THE SAFETY BELT. THE LIFT TIPPED OVER. THERE WAS ONLY ONE STAFF MEMBER PRESENT AT TIME OF INJURY WHO WAS A SUMMER STUDENT. THE FALL RESULTED IN A HIP FRACTURE AND RESIDENT WAS SUBSEQUENTLY TRANSFERRED TO A TERTIARY HOSPITAL FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653486 ALENTI FSA FSA ARJO HOSPITAL EQUIPMENT AB CDB8153-01

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention