PARKER BATH

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

(B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR PARKER BATH, WE HAVE FOUND NUMBER OF OTHER CASES WITH SIMILAR FAULT DESCRIPTION - DEFECTIVE GAS STRUT. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS LOW BUT INCREASING COMPLAINT TREND CONCERNING DEFECTIVE GAS STRUTS, RECORDED UNDER BRAND NAME: PARKER BATH. PLEASE NOTE THAT ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) PARKER BATHS TO DATE. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT TO THE SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. TECHNICAL ADVISORY NOTICE THAT WAS INTRODUCED IN 2007 (TAN SE0607 FROM (B)(4) 2007) CONCERNED OLD TYPE OF GAS STRUTS AND WAS REFERRED TO SALES AND SERVICE UNITS TO INFORM ABOUT IMPORTANCE OF NOTIFYING CUSTOMER THAT: THE PM SCHEDULE STATES THAT AN ANNUAL INSPECTION FOR DAMAGES AND CHECKS OF THE DOOR LOCK AND DOOR OPERATION SHALL BE PERFORMED. (ON TODAY'S MODELS WE HAVE ENHANCED THE MAINTENANCE WITH DAILY AND WEEKLY INSPECTIONS). THE ABOVE INCLUDES THE GAS STRUT AND THE ANCHORS TO VERIFY THAT: THERE ARE NO LOOSE SCREWS, CLIPS OR CRACKS AROUND THE ATTACHMENT OR HINGES ARE ALLOWED. THE GAS STRUT CAN KEEP THE DOOR STABLE AT HIGHEST POSITION (NO SIGN OF DROPPING DOWN IS ALLOWED. TAN PROVIDES ALSO PROCEDURE OF CHECKING AND MAINTAINING GAS STRUT IN OLD PARKER BATH'S MODELS. THE REPORTED EVENT WAS CAUSED BECAUSE THE RETAINING CLIP WAS MISSING WHICH WOULD CAUSE THE STRUT TO BECOME DETACHED. FROM THIS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED AS A RESULT OF POOR MAINTENANCE - MAINTENANCE WAS NOT FOLLOWED AS RECOMMENDED IN PREVENTIVE MAINTENANCE ACTION AS SUGGESTED IN TECHNICAL ADVISORY NOTICE FROM 2007. PLEASE NOTE ALSO THAT THIS BATH WAS IN USE FOR OVER 20 YEARS. THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE PARKER'S MAINTENANCE PROCEDURES WERE FOLLOWED IN ACCORDANCE TO RECOMMENDATIONS, THERE WOULD BE NO PATIENT OR CAREGIVER AT RISK.