BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI TWIN

    MDR report key: 1812382 · Received August 20, 2010

    Report

    Report Number
    9611530-2010-00053
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON THE 2010-(B)(6): (YYYY/MM/DD). DURING TRANSFER FROM BED TO WHEELCHAIR WITH PASSIVE LIFT, THE RIGHT SHOULDER CLIP BROKE IN TWO. THE LIFT WAS ALREADY ABOVE THE WHEELCHAIR. CLIENT LEANED IN THE SLING AND THE RIGHT UPPER ARM FELL TO THE BACK. THERE WERE NO REPORTED INJURIES TO THE CLIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI TWIN LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KTBB4BSX2EU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR