BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIXIE

    MDR report key: 1785813 · Received July 16, 2010

    Report

    Report Number
    9611530-2010-00039
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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) 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 (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. TRACK WISE ID.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): IT IS REPORTED THAT WHILE CLIENT WAS BEING TRANSFERRED FROM BED TO CHAIR, THE BOOM COLLAPSED AND THE CLIENT FELL TO THE FLOOR. IT IS REPORTED VIA NIAIC THAT THE PIN ON THE REAR LINKAGE WAS DISLODGED. NO FURTHER INFORMATION WAS AVAILABLE AS BOTH CUSTOMER CONTACTS UNAVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIXIE LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KTA0100

    Patients

    Seq Age Sex Outcome Treatment
    1