BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBUIFT

    MDR report key: 1812370 · Received August 20, 2010

    Report

    Report Number
    9611530-2010-00055
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT AB (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON THE 2010 (B)(6): (YYYY/MM/DD). THE RESIDENT SAT ON THE BATH SEAT AND WAS RAISED INTO THE BATH. AS THE CHAIR SETTLED IN THE BATH ,THE LADY SHUFFLED FORWARD AND AS SHE DID SO, THE CLIP ON COMMODE SHELL BECAME DETACHED FROM THE CHAIR FRAME. THE RESIDENT WAS LIFTED FROM THE BATH USING ANOTHER HOIST. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBUIFT LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB B TYPE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR