BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALENTI

    MDR report key: 2894209 · Received December 27, 2012

    Report

    Report Number
    9611530-2012-00226
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 3, 2012
    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 · 1

    THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJO HOSPITAL EQUIPMENT AB ON BEHALF OF THE IMPORTER (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 (B)(6) 2012: THE SINGLE STAFF MEMBER HAD COMPLETED THE BATH AND HAD REMOVED THE RESIDENT FROM THE BATH AND HAD STARTED TO DRY THE RESIDENT. THE ALENTI WAS IN AN ELEVATED POSITION, ABOUT 30 OFF THE FLOOR, THE SEAT HEIGHT. THE RESIDENT WAS LEANING BACK AGAINST THE BACK SUPPORT AND SAID SHE HAS A SHARP PAIN IN HER BACK, SHE QUICKLY LEANED FORWARD WHICH CAUSED THE LIFT TO TIP TOWARDS THE CAREGIVER WHO WAS STANDING IN FRONT OF THE INDIVIDUAL. THE STAFF MEMBER TRIED TO CONTROL THE CHAIR AND THE RESIDENT AS THEY SLIPPED TO THE FLOOR. THE RESIDENT'S LEG WAS CAUGHT BETWEEN THE SEAT AND THE FLOOR CAUSING THE BREAK. THE ALENTI HAS A BENT ARM AND THE SEATBELT WAS NOT USED DURING THE BATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB CDB8003-01

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization