RELIANCE MODEL DMI 230

Additional Manufacturer Narrative

I SPOKE WITH THE CLINICAL RISK MGR AT (B)(6) HOSPITAL. (B)(6) STATED THAT THE CHAIR WAS PURCHASED FROM A REFURBISHMENT FACILITY IN (B)(4). RELIANCE MEDICAL PRODUCTS IS IN NO WAY ASSOCIATED WITH (B)(4). (B)(4) IS NOT AN APPROVED SOURCE FOR REFURBISHING OF ANY OF OUR PRODUCTS. DUE TO NOT HAVING ACCESS TO THE SUSPECT PRODUCT, A PROPER EVAL CANNOT OCCUR FOR METHOD, RESULTS, CONCLUSION AS REQUESTED. RELIANCE MEDICAL PRODUCTS POST MARKET SURVEILLANCE DATA INDICATES NO COMPLAINTS PERTAINING TO THE TYPE OF FAILURE REPORTED. RELIANCE MEDICAL PRODUCTS CEASED PRODUCTION AND SHIPMENT OF THIS MODEL IN 2005.

Description of Event or Problem

HEALTH PROFESSIONAL'S IMPRESSION AS DESCRIBED ON (B)(4) HOSPITAL REPORT (B)(4): TITLE: XXXXX. EVENT DESC: RECENTLY, RELIANCE PROCEDURE CHAIRS WERE INSTALLED IN A DERMATOLOGY PRACTICE OFFICE AFFILIATED WITH OUR FACILITY. APPROX 16 DAYS LATER, A PT WAS SITTING IN THE CHAIR TO UNDERGO BIOPSY/EXCISION OF AN EAR LESION. PRIOR TO EXCISION, THE CHAIR AND PATIENT ABRUPTLY FELL FROM THE ELEVATED POSITION TO THE FLOOR. THE PATIENT DID NOT FALL OFF OF THE CHAIR, BUT THE CHAIR DID ABRUPTLY HIT THE GROUND. A YELLOW COLORED FLUID (PRESUMED TO BE HYDRAULIC FLUID) BEGAN LEAKING FROM THE CHAIR. THE PATIENT SUFFERED NO APPARENT INJURY. THE VENDOR WAS NOTIFIED AND WILL BE SENDING SERVICE TECHNICIANS TO EVALUATE AND REPAIR THE EQUIPMENT.