BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 1746515 · Received June 30, 2010

    Report

    Report Number
    9611530-2010-00029
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 28, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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, ARJO INC, (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-06-01: CAREGIVER WAS LIFTING RESIDENT OUT OF TUB WHEN LEFT FRONT CASTER FELL OFF AND RESIDENT ROLLED TO FLOOR. NO INJURIES. RESIDENT GOT UP UNDER HIS OWN POWER AND SAT DOWN IN WHEELCHAIR. IT WAS REPORTED THAT THE ALENTI HAS BEEN HARD TO MOVE FOR A WHILE. (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 CDB8153-01

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR