UNIVERSAL COUCHTOP RECTANGULAR EXTENSION

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.