BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL COUCHTOP RECTANGULAR EXTENSION

    MDR report key: 1725408 · Received June 11, 2010

    Report

    Report Number
    1932738-2010-00002
    Event Type
    Other
    Date Received
    June 11, 2010
    Date of Event
    May 21, 2010
    Report Date
    June 11, 2010
    Manufacturer
    MEDTEC, INC.
    Product Code
    IXQ
    PMA / PMN Number
    K973842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: LOCKING MECHANISM. METHOD: DISTRIBUTOR'S DESCRIPTION OF EVENTS WERE REVIEWED. THESE OBSERVATIONS DESCRIBED WERE ABLE TO BE DUPLICATED WITH PRODUCT EVALUATED FROM INVENTORY BY MECHANICALLY DISTRIBUTING A LOAD UNEVENLY ACROSS THE DEVICE. RESULTS: CLINICIANS DID NOT FOLLOW INSTRUCTIONS FOR USING THE DEVICE AND ALLOWED PATIENTS TO REPOSITION THEMSELVES WITHOUT AID. UNEVEN LOADING AND SHIFTING ON THE DEVICE RESULT IN A FORCE PLACED ON THE AXEL OF THE LOCKING MECHANISM RESULTING IN ITS ROTATING UNTIL IT REACHES THE RELEASE POINT AND THE EXTENSION DISENGAGES. CONCLUSION: USER ERROR ALLOWING PATIENT TO REPOSITION UNAIDED CONTRIBUTED TO DEVICE FAILURE. REMEDIAL ACTION INITIATED: NOTIFICATIONS SENT TO CUSTOMERS IDENTIFYING THE POTENTIAL FAILURE METHOD FOR THE EXTENSION AND PROVIDING REMINDERS ON HOW TO UTILIZE THE PRODUCT. NEW RE-DESIGNED LATCHES WITH POSITIVE LOCKING FEATURE ARE BEING SENT OUT TO ALL CUSTOMERS TO REPLACE THE CURRENT LATCHES ON THEIR EXTENSION UNITS.

    Description of Event or Problem · 1

    PRONE PATIENT CLIMBED ONTO THE COUCH WITH HIS HEAD AND SHOULDERS OVER THE EXTENSION. HE WAS THEN ASKED TO MOVE AND GRABBED THE SIDES OF THE EXTENSION WITH HIS HANDS LIFTING HIMSELF UP SLIGHTLY. THE EXTENSION THEN CAME FREE OF THE MAIN COUCH RESULTING IN THE PATIENT FALLING TO THE FLOOR AND HITTING HIMSELF UPON THE THERAVIEW IMAGING UNIT. THE PATIENT WAS DESCRIBED AS LARGE BUT NOT THE LARGEST. THE PATIENT APPEARED UNHARMED AND CONTINUED TREATMENT ON A DIFFERENCE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL COUCHTOP RECTANGULAR EXTENSION UNIVERSAL COUCHTOP RECTANGULAR EXTENSION IXQ MEDTEC, INC. MTIL6600 M161450

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE.