EXTENSION ARM, 50CM
Received Mar 4, 2016 · Event occurred Feb 4, 2016
Report 9611102-2016-00002 · MDR key 5481926
Device
Product problems
- Component Falling
- Component Falling
Patient
Not reported
- No Patient Involvement
- No Known Impact Or Consequence To Patient
- No Patient Involvement
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PHOTO OF MONITOR, BRACKET AND CART SUBMITTED. INVESTIGATION/EVALUATION CURRENTLY IN PROCESS. (B)(4) CONSIDERS THIS REPORT OPEN, FOLLOW UP REPORT TO BE SUBMITTED ONCE INVESTIGATION IS COMPLETE.
Description of Event or Problem
A MONITOR FELL OFF ITS BRACKET STRIKING A MEMBER OF THE STAFF ON THE SHOULDER WHILE SHE WAS TRYING TO POSITION THE MONITOR. NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE EXTENSION ARM WAS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION (FSCA) IN 2013. REVIEW OF THE DOCUMENTATION OF THE FSCA FROM 2013 FOUND A HOLDER PLATE WAS MOUNTED ON THE DEVICE IN QUESTION AT (B)(6) IN 2013. FACILITY PROVIDED RW(B)(4) A PHOTO OF DROPPED MONITOR AND THE HOLDER PLATE APPEARED TO BE MISSING. ABSENT OF HOLDER PLATE WAS CONFIRMED ONCE DEVICE WAS RETURNED FOR INVESTIGATION. RW (B)(4) IS UNABLE TO DETERMINE WHO REMOVED PLATE, WHEN IT WAS REMOVED OR THE REASON FOR REMOVING THE PLATE. THERE HAVE BEEN NO SIMILAR ISSUES ON (B)(4) EXTENSION ARMS WITH MOUNTED HOLDER PLATES SINCE FSCA IN 2013. FROM OUR POINT OF VIEW THERE IS NO DOUBT ABOUT THE EFFECTIVENESS OF THE CORRECTIVE ACTION IN 2013. (B)(4) CONSIDERS THIS REPORT TO BE CLOSED. IF ANY ADDITIONAL INFORMATION IS RECEIVED CONCERNING THIS EVENT, AN ADDITIONAL FOLLOW UP REPORT WILL BE PROVIDED. (B)(4).