BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE CONTINENTAL B

    MDR report key: 2238442 · Received September 1, 2011

    Report

    Report Number
    3003984900-2011-00035
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 29, 2011
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD - AKRON
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE MFR ARJOHUNTLEIGH, A BRANCH OF ARJO (B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE HUNTLEIGH HEALTHCARE LTD ((B)(4)). AS OF 2011, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, A BRANCH OF ARJO LIMITED MED AB AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT DURING TREATMENT OF A PT THAT WAS LYING ON A STREAMLINE CONTINENTAL COUCH, THE GAS STRUT UNDERNEATH THE LEG SECTION SUDDENLY BROKE OFF; THE FASTENING WITH THE UPHOLSTERY IS ALSO BROKEN. THE PT HIT HER KNEES AND SUFFERED A MINOR IMPACT TO HER BACK, BUT THERE WERE NO REPORTED INJURIES SUFFERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STREAMLINE CONTINENTAL B COUCH FNL HUNTLEIGH HEALTHCARE LTD - AKRON A2232B/2/SFS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other