BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 3221154 · Received July 5, 2013

    Report

    Report Number
    9611530-2013-00075
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). PLEASE NOTE THAT ONLY AS RECENT AS (B)(6) 2013, WE HAVE RECEIVED OUR FIRST CLEAR INDICATION BY A CUSTOMER THAT ALLOWED US TO IDENTIFY THERE TO BE AN ISSUE AND POSSIBLE MALFUNCTION OF THIS BELT THAT MAY LEAD TO CAUSE SERIOUS INJURY OR DEATH SHOULD THE USER NOT OBSERVE INDICATIONS IN THE DEVICE LABELING: TO HAVE THE PERSON ON THE DEVICE IN THE CENTER OF THE CHAIR AND EVALUATE THEM BEFORE USE. SUBSEQUENTLY, WE HAVE STARTED PERFORMING SIMULATIONS THAT SHOWS THERE MAY BE A RISK. THEREFORE, WE HAVE NOW DECIDED TO REPORT HENCEFORTH COMPLAINTS WHERE IT IS INDICATED THE BELT BUCKLE WAS NOT CORRECTLY FUNCTIONING. THIS MEANS THAT WE REPORT THIS COMPLAINT WITH AN ORIGINAL AWARENESS DATE OF MORE THAN 30 DAYS BEFORE TODAY. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    REF IMP REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307093 ALENTI FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1