BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 2019954 · Received March 10, 2011

    Report

    Report Number
    9611530-2011-00025
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 27, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4), THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (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 2011-(B)(6): (B)(6) POTENTIAL REPORT - LPN WAS TRANSFERRING RESIDENT INTO TUB USING THE ALENTI CHAIR LIFT. WHILE ALENTI WAS RAISED THE LPN WENT TO TURN THE ALENTI SO RESIDENT'S FEET AND LEGS WERE IN THE TUB BUT ALENTI AND STAND FELL TOWARDS LPN. APPARENTLY A WHEEL BROKE OFF. THE FULL WEIGHT OF THE LIFT CHAIR AND THE RESIDENT WAS APPLIED SUDDENLY ONTO LPN. CAREGIVER: HURT BACK, SORENESS. COMPLAINED OF PAIN AND IS NOW OFF FOR AT LEAST 1 WEEK. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1