CITIA STAIRWAY CHAIRLIFT
Received Dec 14, 2011 · Event occurred Nov 21, 2007
Report 1925312-2011-00001 · MDR key 2380852
Device
Generic name
Powered Patient Transport 890.5150
Manufacturer
Thyssenkrupp AccessModel number
CITIACatalog number
SL47
Lot number
NA
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
THIS FORM FDA 3500A IS BEING SUBMITTED TO CONFIRM THAT BY LETTER OF (B)(4), 2011, TK ACCESS PROVIDED A COPY OF A FORMAL COMPLAINT REGARDING AN INCIDENT WITH THIS MEDICAL DEVICE. AT THIS TIME, TK ACCESS HAS NOT BEEN GIVEN THE OPPORTUNITY TO INSPECT THE LIFT AND FOR THAT REASON HAS NOT BEEN ABLE TO EVALUATED THE CLAIM THAT THE LIFT MALFUNCTIONED.
Description of Event or Problem
ACCORDING TO INFO RECEIVED, (B)(6) AND ANOTHER PERSON, WERE ATTEMPTING TO PICK A PT UP FROM THE STAIRWAY CHAIR LIFT IN ORDER TO TRANSFER HER TO A GURNEY/STRETCHER. DURING THIS TIME, MR. (B)(6) BRACED HIS RIGHT LEG ON THE STAIRS NEXT TO THE LIFT. THE PT'S NEPHEW ALLEGEDLY TURNED ON THE LIFT USING THE REMOTE CONTROL AND THE LIFT MOVEMENT PINNED MR. (B)(6) LEG BETWEEN THE LIFT AND THE STAIRS.