PARKER BATH

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

(B)(4). THE PARKER BATH IS A HEIGHT ADJUSTABLE BATH SYSTEM INTENDED FOR ASSISTED BATHING. IT WAS REPORTED TO US THAT THE WATER TEMPERATURE OF THE BATH WAS FLUCTUATING AND THAT THE FACILITY MAINTENANCE STAFF HAD DEACTIVATED THE MECHANICAL SCALDING PROTECTION IN TRYING TO SOLVE THE ISSUE. AN ARJOHUNTLEIGH TECHNICIAN VISITED SITE TO INSPECT AND REPAIR THE BATH. THE MANUFACTURER'S INVESTIGATION IS COMPLETED AND CONCLUDES: A REVIEW OF PREVIOUS COMPLAINTS SHOWS NO TREND OF SIMILAR EVENTS. THE ROOT CAUSE OF THIS EVENT IS NEGLECTED MAINTENANCE IN COMBINATION WITH AN UNAUTHORIZED USE OF THE PRODUCT. THE PARKER BATH 420 HAS A 2 STEP MECHANICAL SCALDING PROTECTION. THE CARTRIDGES IN THE MIXER CONTAINS A WAX BULB THAT ADJUSTS THE TEMPERATURE AND BEHIND THE CONTROL KNOB A SECOND MECHANICAL SCALDING PROTECTION ASSURES THAT THE MAXIMUM HOT WATER IS CALIBRATED AT INSTALLATION AND SHOULD BE TESTED AT YEARLY MAINTENANCE. THE PREVENTIVE MAINTENANCE SCHEDULE FOR PARKER 420 ALSO STATES THAT THE CARTRIDGE SEALS SHOULD BE DESCALED AND REPLACED YEARLY AND THAT CARTRIDGES SHOULD BE REPLACED EVERY THIRD YEAR. THESE MAINTENANCE ACTIVITIES NEED TO BE PERFORMED BY QUALIFIED SERVICE PERSONNEL. IT IS STATED IN THE IFU (04.AL.00/3 GB FROM NOVEMBER 2005) THAT "MANDATORY MAINTENANCE SHALL BE CARRIED OUT BY FULLY TRAINED, QUALIFIED SERVICE PERSONNEL USING THE CORRECT TOOLS AND WITH KNOWLEDGE OF THE MAINTENANCE PROCEDURES: FAILURE TO MEET THESE REQUIREMENTS COULD RESULT IN PERSONAL INJURIES AND/OR UNSAFE EQUIPMENT." IT APPEARED THAT THE FACILITY MAINTENANCE STAFF HAS FAILED TO FOLLOW THE PREVENTIVE MAINTENANCE SCHEDULE FOR THE PRODUCT IN RESPECT TO CLEAN AND REPLACE THE CARTRIDGES. THE CLOGGED CARTRIDGES HAVE CAUSED A TOO LOW WATER TEMPERATURE. IN ORDER TO TRY TO SOLVE THIS ISSUE THE FACILITY MAINTENANCE STAFF HAS ADJUSTED THE CONTROL KNOB SCALDING PROTECTION AND MADE IT POSSIBLE FOR WATER WITH 50+ DEGREES C TO ENTER THE BATH. TO CONCLUDE THE FACILITY APPEARS TO HAVE FAILED TO FOLLOW THE REQUIRED MAINTENANCE REQUIREMENTS AND ALSO MODIFIED THE BATH IN AN UNAUTHORISED WAY BY DE-ACTIVATING THE MECHANICAL SCALDING PROTECTION. THE ON-SITE ARJOHUNTLEIGH TECHNICIAN HAS REPAIRED THE BATH AND EXPLAINED TO THE MAINTENANCE MANAGER THE NEED TO EDUCATE THE MAINTENANCE STAFF. IT CAN BE CONCLUDED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. IT CAN BE CONCLUDED THAT IT WAS NOT BEING USED FOR TREATMENT OR DIAGNOSIS AT THE TIME OF THE EVENT. IT CAN BE CONCLUDED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.