BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALENTI

    MDR report key: 1910456 · Received November 18, 2010

    Report

    Report Number
    9611530-2010-00118
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ARJO HOSP EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA. ARJOHUNTLEIGH INC., (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): PER THE AHUS SERVICE TECH - "TODAY DURING A BATH, THIS ALENTI BATHING CHAIR WITH RESIDENT TIPPED OVER, (B)(4) SENDING THE RESIDENT TO THE FLOOR. THE FOLLOWING DETAILS WERE PROVIDED; (B)(4) (THE CARE PROVIDER) WAS PROVIDING THE RESIDENT WITH A TYPICAL BATH. THE RESIDENT WAS BROUGHT INTO THE BATHING ROOM (20 FEET BY 20 FEET) THE RESIDENT WAS TRANSFERRED ONTO THE BATH CHAIR. (B)(6) TRANSFERRED THE RESIDENT INTO THE P300 TUB AND THE BATH WAS PROVIDED. WITH THE RESIDENT'S BATH COMPLETE, (B)(6) LOWERED THE TUB AND RAISED THE TUB CHAIR TO CLEAR EDGE OF THE TUB. WITH THE RESIDENT CLEAR OF THE TUB THE ALENTI AND RESIDENT WERE MOVED AWAY FROM THE TUB, WITH (B)(6) STANDING BY THE HEAD AREA OF THE TUB AND THE ALENTI AND RESIDENT BACK BY THE BACK AREA OF THE TUB SHELL. AT THIS POINT (B)(6) TURNED TO THE HEAD AREA OF THE TUB WHEN SHE SAID THE ALENTI WITH RESIDENT HAD TIPPED OVER. A RN WAS WAITING JUST OUTSIDE THE DOOR TO CONDUCT A SKIN ASSESSMENT, IMMEDIATELY THIS RN CAME INTO THE ROOM AND ASSISTED (B)(4) WITH THE CARE TO THE RESIDENT. THE RESIDENT HAD SLID DOWN THE SEAT AREA, STILL RESTRAINED FROM THE RESIDENT SAFETY BELT APPLIED. THE RESIDENT'S LEGS WERE ON THE FLOOR WITH THE ALENTI LEG ARM ON TOP OF HER LEGS. THE SAFETY BELT WAS REMOVED AND THE ALENTI LIFT WAS MOVED AWAY FROM THE RESIDENT. THE RESIDENT WAS EXAMINED FOR INJURIES, AND RETURNED TO HER ROOM FOR ADDITIONAL OBSERVATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSP EQUIPMENT AB CDB8053-01

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR