PARKER BATH

Additional Manufacturer Narrative

THE DEVICE WAS INSPECTED BY AN ARJO SERVICE TECHNICIAN. THE INSPECTION REVEALED THAT THE DOOR HANDLE MECHANISM REQUIRED ADJUSTMENT. THE DEVICE WAS REPAIRED. PROCESS OF ANALYZING INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

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 ARJOHUNT LEIGH 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.

Description of Event or Problem

ARJO WAS NOTIFIED OF AN EVENT INVOLVING THE PARKER BATHTUB. IT WAS REPORTED THAT A PATIENT WAS IN THE BATHTUB WHEN THE DOOR HANDLE UNEXPECTEDLY RELEASED AND THE PARKER BATHTUB DOOR OPENED. NO INJURIES WERE SUSTAINED BY THE PATIENT.

Additional Manufacturer Narrative

AADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

Additional Manufacturer Narrative

ARJO WAS NOTIFIED OF AN EVENT INVOLVING THE PARKER BATHTUB. IT WAS REPORTED THAT A PATIENT WAS IN THE BATHTUB WHEN THE DOOR HANDLE UNEXPECTEDLY RELEASED AND THE PARKER BATHTUB DOOR OPENED. NO INJURIES WERE SUSTAINED BY THE PATIENT. BASED ON THE DEVICE'S INSPECTION RESULTS, IT WAS DETERMINED THAT THE BOLT CONNECTING THE HANDLE TO THE MECHANISM WAS SLIGHTLY LOOSE, CAUSING THE PARKER BATHTUB DOOR TO OPEN UNEXPECTEDLY. THE FINDINGS WERE CONSULTED WITH THE TECHNICAL DEPARTMENT TO FURTHER INVESTIGATE POSSIBLE FACTORS WHICH MAY HAVE CONTRIBUTED TO THE HANDLE COMING LOOSE. THE HANDLE ASSEMBLY USES A SELF-LOCKING NUT AND BOLT, THEREFORE NO LOOSENING SHOULD OCCUR AT THIS CONNECTION. HOWEVER, DUE TO DOOR ASSEMBLY ISSUES (FIT PROBLEMS), THE DOOR MAY CLOSE WITH DIFFICULTY AND A LARGE FORCE MUST THEN BE APPLIED TO THE HANDLE. AS A RESULT, THE HANDLE BOLT MAY BE DEFECTIVE. THE PARKER BATH INSTRUCTION FOR USE (IFU) (04.AL.01_7) 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, 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.