PARKER BATH

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

(B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR PARKER BATH AND OTHER BATHS, WE HAVE FOUND NUMBER OF OTHER CASES WITH SIMILAR FAULT DESCRIPTION (LEGIONELLA ISSUE). WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND CONCERNING LEGIONELLA ISSUE IN BATHS RECORDED UNDER BRAND NAME: PARKER BATH. THE TREND OBSERVED FOR REPORTABLE COMPLAINTS ON BATHS DEVICES IS CONSIDERED TO BE LOW AND STABLE TAKING INTO CONSIDERATION OVER (B)(4) UNITS ON FIELD. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE THE SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. WATER SUPPLY REQUIREMENTS ARE INCLUDED ASSEMBLY AND INSTALLATION MANUAL (06.AL.00_3GB): MAXIMUM SUPPLY TEMPERATURE HOT WATER - TMV3 (D08) WATER PANEL: 80 C (176 F), MAXIMUM SUPPLY TEMPERATURE HOT WATER - TMV3 (D08) WATER PANEL (UK): 65 C (149 F), MAXIMUM SUPPLY TEMPERATURE HOT WATER - TMV3 (D08) WATER PANEL: 44 C (110 F), MAXIMUM SUPPLY TEMPERATURE HOT WATER - TMV3 (D08) WATER PANEL (UK AND EUROPE): 52 C (126F), RECOMMENDED SUPPLY TEMPERATURE HOT WATER - TMV3 (D08) WATER PANEL: 52 C - 65 C (126 F - 149 F), MAXIMUM SUPPLY TEMPERATURE COLD WATER - TMV3 (D08) WATER PANEL: 20 C (68 F). THE INSTRUCTION FOR USE (09.AL.00/1GB FROM JUNE 2003) PROVIDE ALSO INFORMATION ABOUT MAINTENANCE OF THE DEVICE: EVERY DAY CAREGIVER IS OBLIGED TO CLEAN USED DEVICE. IF THE RECOMMENDATIONS THE INSTRUCTION FOR USE AND ASSEMBLY AND INSTALLATION MANUAL ARE FOLLOWED AND THE HOT AND COLD WATER TEMPERATURE IS UNDER CONTROL IT IS UNLIKELY FOR LEGIONELLA TO BE FOUND IN THE BATH. BECAUSE THIS PROBLEM RE-OCCURRED IT CAN BE ALSO CONCLUDED THAT PROBLEM WAS CAUSED BY INCORRECT REPAIR OR FACILITY'S WATER INSTALLATION. WE CONSIDER IT IS HIGHLY UNLIKELY THAT THE LEGIONELLA CONTAMINATION ORIGINATES FROM THE BATH SYSTEM BUT RATHER FROM THE FACILITY PIPES. FROM THIS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED AS A RESULT OF STAFF INCORRECTLY OR NOT FOLLOWING PROCEDURES AS INDICATED IN THE INSTRUCTIONS FOR USE AND PREVENTIVE MAINTENANCE INSTRUCTION OF THE DEVICE. AS THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF PREVENTIVE MAINTENANCE HAS BEEN CORRECTLY PERFORMED THERE WILL BE NO PATIENT OR CAREGIVER RISK. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. ARJOHUNTLEIGH WILL TRACK AND TREND THE ISSUE AND IF THE PROBLEM ARISE, THE PROPER ACTIONS WILL BE TAKEN.