PARKER BATH

Description of Event or Problem

ARJO RECEIVED A CUSTOMER COMPLAINT REGARDING A PARKER BATH. THE CUSTOMER REPORTED AN ISSUE WITH THE BATH DOOR. NO INJURIES OR HEALTH CONSEQUENCES WERE REPORTED BY THE FACILITY. FOLLOWING AN INSPECTION CONDUCTED BY ARJO, IT WAS FOUND THAT THE DOOR OF THE PARKER BATH WAS FALLING DUE TO A FAILURE OF THE GAS STRUT. DESPITE THE DEFECT, THE CUSTOMER CONTINUED TO USE IT.

Additional Manufacturer Narrative

PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED UNDER THE REGISTRATION NUMBER: (B)(4). CURRENTLY, THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH ABS COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION#: (B)(4). THE DOOR OF THE PARKER (420) BATH CAN BE OPENED BY PULLING THE LEVER DOWN AND LIFTING THE DOOR UPWARD. THE GAS STRUT IS CALIBRATED TO ASSIST WITH DOOR OPENING AND TO MAINTAIN DOOR BALANCE IN THE RAISED POSITION, PREVENTING IT FROM FALLING. A GAS STRUT IS A HYDRAULIC COMPONENT CONSISTING OF A CHAMBER FILLED WITH OIL AND AIR, WHICH IS COMPRESSED BY A ROD PUSHING A PISTON INTO THE CHAMBER. THE MOVEMENT OF THESE PARTS IS SEALED BY HYDRAULIC SEALS. OVER TIME, THESE SEALS MAY BEGIN TO LEAK AIR AND OIL, CAUSING THE PERFORMANCE OF THE STRUT TO GRADUALLY DETERIORATE. EVENTUALLY, THE STRUT MAY NO LONGER FULLY SUPPORT THE WEIGHT OF THE DOOR. THIS GRADUAL DETERIORATION IS TYPICALLY NOTICEABLE DURING DAILY USE. THE DEVICE HISTORY OF SERVICE REPAIRS AND INFORMATION RECEIVED REVEALED THAT THE GAS STRUT WAS NEVER REPLACED IN THE PAST - SINCE DATE OF MANUFACTURING (2006). THE OPERATING AND DAILY MAINTENANCE INSTRUCTIONS FOR PARKER BATH INFORM THE USER THAT THE EQUIPMENT IS SUBJECT TO WEAR AND TEAR, AND RECOMMENDED MAINTENANCE INSTRUCTIONS MUST BE PERFORMED WHEN SPECIFIED TO ENSURE THAT THE EQUIPMENT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION. BASED ON THE PERFORMED ANALYSIS AND INFORMATION RECEIVED IN THE COURSE OF THIS INVESTIGATION, IT SEEMS THAT THE ROOT CAUSE MIGHT BE RELATED TO NORMAL WEAR OF THE COMPONENT. AT THE TIME OF EVENT THE DEVICE DID NOT MEET MANUFACTURER SPECIFICATION DUE TO WORN DOOR GAS STRUT. IT WAS UNKNOWN IF THE BATHTUB WAS USED FOR PATIENT HYGIENE. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE REGULATORY AUTHORITIES DUE TO GAS STRUT MALFUNCTION LEADING TO BATH¿S DOOR FALLING AND BECAUSE THE DEVICE WAS NOT REMOVED FROM SERVICE. NO UDI INFORMATION IS AVAILABLE; THE DEVICE WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.