PARKER BATH

Additional Manufacturer Narrative

ARJO WAS NOTIFIED OF AN EVENT INVOLVING THE PARKER BATHTUB. IT WAS REPORTED THAT A RESIDENT WAS IN THE BATHTUB, WHICH WAS FILLING WITH WATER. IT WAS INDICATED THAT THE DOOR HANDLE UNEXPECTEDLY RELEASED AND THE PARKER BATHTUB DOOR OPENED, RELEASING WATER FROM INSIDE THE BATHTUB. NO INJURIES WERE SUSTAINED BY THE RESIDENT. THE PARKER BATH INSPECTION PERFORMED BY THE ARJO SERVICE TECHNICIAN AFTER THE EVENT REVEALED THAT THE DOOR LOCKING MECHANISM MOUNTED WITHIN DOOR LOCKS BUT THEN OPENED UNEXPECTEDLY ON ITS OWN. HE INDICATED THAT THE DOOR HANDLE LATCH SYSTEM WAS WORN. IT FATIGUED AFTER ABOUT 10 YEARS OF USE AND REQUIRED REPLACEMENT. THE PARKER BATH IS SUBJECT TO WEAR AND TEAR, AND SOME ACTIONS MUST BE PERFORMED WHEN SPECIFIED TO ENSURE THAT THE PRODUCT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION. TO AVOID MALFUNCTION RESULTING IN INJURY, THE USER SHOULD MAKE SURE TO CONDUCT REGULAR INSPECTIONS AND FOLLOW THE RECOMMENDED MAINTENANCE SCHEDULE PROVIDED WITHIN THE PARKER INSTRUCTIONS FOR USE (IFU). ACTIONS BEFORE EVERY USE: "IF ANY PART IS MISSING OR DAMAGED - DO NOT USE THE PRODUCT". IN SECTION ¿CARE AND PREVENTIVE MAINTENANCE¿ IN THE IFU THE PREVENTIVE MAINTENANCE SCHEDULE IS AVAILABLE, WHICH INCLUDES THE OBLIGATION TO CHECK DOOR ON A WEEKLY BASIS: ¿OPEN AND CLOSE THE DOOR AND CHECK ITS SUPPORTS FOR CORRECT FUNCTION I.E THE DOOR SHOULD NOT DROP BY ITSELF DURING CLOSING. CHECK THE LOCK FOR PROPER FUNCTION.¿ BASED ON THE COLLECTED INFORMATION, IT CAN BE CONCLUDED THAT THE CAUSE OF THE DOOR LOCK MECHANISM FAILURE COULD BE RELATED TO THE NORMAL WEAR OF THE PART. IN SUMMARY, ACCORDING TO THE GATHERED INFORMATION, THE PARKER BATH'S DOOR OPENED DURING PATIENT¿S BATHING, THEREFORE FROM THIS PERSPECTIVE, THE BATHING SYSTEM DID NOT MEET THE PERFORMANCE SPECIFICATION. THE BATH WAS USED FOR PATIENT HYGIENE AND IN THAT WAY IT PLAYED A ROLE IN THIS EVENT. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITY DUE TO THE OPENING OF THE BATH DOOR WHILE THE PATIENT WAS IN THE BATH, AND THE FAILURE WAS NOT DETECTED PRIOR TO USE.

Additional Manufacturer Narrative

PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED UNDER THE REGISTRATION NUMBER 9611530. CURRENTLY, THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH ABS COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

Description of Event or Problem

ARJO WAS NOTIFIED OF AN EVENT INVOLVING THE PARKER BATHTUB. IT WAS REPORTED THAT A RESIDENT WAS IN THE BATHTUB, WHICH WAS FILLING WITH WATER. IT WAS INDICATED THAT THE DOOR HANDLE UNEXPECTEDLY RELEASED AND THE PARKER BATHTUB DOOR OPENED, RELEASING WATER FROM INSIDE THE BATHTUB. NO INJURIES WERE SUSTAINED BY THE RESIDENT.