BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIANCA

    MDR report key: 2659568 · Received July 17, 2012

    Report

    Report Number
    9611530-2012-00106
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO MED (B)(4). PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED (B)(4). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSPITAL EQUIPMENT (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER TO THE REGIONAL SERVICE MANAGER THAT THE BIANCA WOUND DOWN ON IT'S OWN DURING USE. THE SERVICE USER WAS HOISTED TO A FLOOR MAT FOR TREATMENT. THE HANGER WAS RAISED TO TOP LIMIT THEM TRAVERSED OUT OF THE AREA. ONCE THE SESSION WAS COMPLETED, THE HOIST WAS TRAVERSED BACK INTO POSITION, WITH A VIEW TO LIFTING THE SERVICE USER OFF THE FLOOR MAT, BACK ONTO A CHAIR/STRETCHER AT WHICH POINT WITHOUT ANY PROMPTING THE HANGER CRASHED TO THE FLOOR ONLY JUST MISSING THE USER ON THE FLOOR. VARIOUS STAFF WERE PRESENT AT THE TIME, ALTHOUGH THE ONLY WITNESS NAME SUPPLIED WAS (B)(4), WHO WAS NOT PRESENT DURING THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIANCA CEILING LIFTS FSA ARJO MED AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1