PARKER BATH

Description of Event or Problem

ARJO WAS INFORMED ABOUT AN EVENT RELATED TO A PARKER BATH. IT WAS REPORTED THAT DURING THE USE OF THE BATH WITH A PATIENT, THE BATH DOOR OPENED AND WATER DRAINED ONTO THE FLOOR. THE PARKER BATH DOOR LATCH WAS NOT WORKING CORRECTLY. NO INJURY WAS REPORTED.

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). PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION. THE UDI NUMBER IS NOT AVAILABLE AS THE DEVICE WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.

Additional Manufacturer Narrative

ARJO WAS INFORMED ABOUT AN EVENT RELATED TO A PARKER BATH. IT WAS REPORTED THAT DURING THE USE OF THE BATH WITH A PATIENT, THE BATH DOOR OPENED AND WATER DRAINED ONTO THE FLOOR. THE PARKER BATH DOOR LATCH WAS NOT WORKING CORRECTLY. NO INJURY WAS REPORTED. BASED ON THE DEVICE'S INSPECTION RESULTS, IT WAS DETERMINED THAT THE DOOR LOCK WAS DETERIORATED. THE SQUARE KEYHOLE WAS COMPLETELY ROUNDED ON ONE SIDE, WHICH LED TO THE DOOR LEVER COMING LOOSE AND SLIPPING ON THE SQUARE KEY. AS A RESULT, THE DOOR DID NOT LATCH PROPERLY AND OPENED. POST-MARKET SURVEILLANCE DATA REVEALED THAT FAILURE OF THE BATH LOCKING MECHANISM CAN OCCUR DUE TO WEAR OF THIS PART. A REVIEW OF SERVICE RECORDS SHOWED THAT THE DOOR LOCK MECHANISM HAD NOT BEEN REPLACED ON THIS PRODUCT BEFORE. THEREFORE, A COMPONENT FAILURE DUE TO NORMAL WEAR CANNOT BE RULED OUT. THE PARKER BATH INSTRUCTION FOR USE (IFU) (04. AL.01) INCLUDES THE FOLLOWING INFORMATION: 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.¿ IN SUMMARY, THE PARKER BATH'S DID NOT MEET THE PERFORMANCE SPECIFICATION DUE TO DOOR MECHANISM MALFUNCTION. 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.