PARKER BATH

Additional Manufacturer Narrative

(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN THE NEXT REPORT.

Description of Event or Problem

IT WAS REPORTED THAT WHILE CAREGIVER WAS ASSISTING THE PATIENT IN THE BATH, THE DOOR FELL DOWN AND HIT THE CAREGIVER ON THE HEAD. ACCORDING TO THE RECEIVED INFORMATION THE CAREGIVER SUSTAINED A HEAD INJURY. NO FURTHER DETAILS REGARDING OUTCOME AND TREATMENT ARE CURRENTLY AVAILABLE. PLEASE NOTE THAT ARJO WAS NOTIFIED ABOUT THE EVENT WITH A DELAY. ARJO REPRESENTATIVE WILL CONTACT THE CUSTOMER FACILITY TO OBTAIN MORE INFORMATION IF AVAILABLE.

Additional Manufacturer Narrative

ON (B)(6) 2018 ARJO WAS NOTIFIED ABOUT THE EVENT INVOLVING PARKER BATH. IT WAS REPORTED THAT WHILE CAREGIVER WAS ASSISTING THE PATIENT IN THE BATH, THE DOOR FELL DOWN AND HIT THE CAREGIVER ON THE HEAD. ACCORDING TO THE RECEIVED INFORMATION, THE CAREGIVER SUSTAINED A HEAD INJURY. NO FURTHER DETAILS REGARDING INJURY AND APPLIED TREATMENT WERE MADE AVAILABLE. ARJO REPRESENTATIVE WAS INFORMED ABOUT THE EVENT WITH A DELAY (APPROXIMATELY 2 YEARS AFTER THE INCIDENT OCCURRED). ARJO REPRESENTATIVE CONTACTED THE CUSTOMER FACILITY BY E-MAIL AND BY PHONE AND HAS MADE MULTIPLE ATTEMPTS TO REACH A PERSON, WHO MAY BE ABLE PROVIDE ADDITIONAL INFORMATION AND CONFIRMATION OF THE EVENT OCCURRENCE, BUT WITHOUT SUCCESS. THE CLAIMED PARKER BATH WAS NOT UNDER THE ARJO SERVICE AGREEMENT AT THE TIME WHEN THE EVENT OCCURRED. HOWEVER, ACCORDING TO THE HISTORY OF REPAIRS FOR THIS DEVICE, THE ARJO QUALIFIED PERSONNEL SERVICED THE UNIT 3 TIMES WITHIN THE PERIOD CLOSE TO THE EVENT'S OCCURRENCE DATE. ON (B)(6) 2016 THE ARJO WAS REQUESTED FOR SERVICE AND THE ARJO REPRESENTATIVE REPLACED THE FAULTY DOOR GAS STRUT. NEXT SERVICE WAS PERFORMED ON 2016-NOV-30. DURING THE INSPECTION THE ARJO REPRESENTATIVE FOUND THAT GAS STRUT SOCKET (PIVOT KNUCKLE) SECTION DETACHED FROM THE THREADED END OF THE LOWER PART OF THE GAS STRUT. THIS REQUIRED THE INSPECTION OF THE GAS STRUT. ACCORDING TO THE RECEIVED SERVICE INFORMATION, IT SHOWED NO SIGNS OF WEAR OR DAMAGE, SO IT WAS REFITTED AND FUNCTION TESTED AFTERWARDS. AFTER ABOUT A MONTH, THE NEXT REPAIR REQUEST WAS RECEIVED. ON 2017-JAN-09 THE ARJO QUALIFIED EMPLOYEE VISITED THE FACILITY AGAIN AND FOUND THAT THE FAILURE RECURRED. AT THIS TIME, THE NEW GAS STRUT WAS INSTALLED AND BATH WAS TESTED AFTER THE REPLACEMENT. PLEASE NOTE THAT THE ARJO REPRESENTATIVE WAS NOT INFORMED ABOUT THE INCIDENT AND CIRCUMSTANCES OF ITS OCCURRENCE AT ANY OF THESE VISITS. BASED ON THE PROVIDED DATE OF EVENT THE INCIDENT OCCURRED AT (B)(6) 2016. THEREFORE, THE REPAIR OF THIS DEVICE WAS MOST PROBABLY PERFORMED ON (B)(6) 2016. THE DOOR GAS STRUT, WHICH FAILED, WAS THEN A NEW PART INSTALLED A FEW DAYS EARLIER BEFORE THE INCIDENT. THE ARJO TECHNICIAN REPLACED THE FAULTY PART AND THEN DISPOSED IT. MOREOVER, DUE TO THE LONG TIME PASSED FROM THE ALLEGED INCIDENT OCCURRENCE IT WAS NOT POSSIBLE TO OBTAIN DETAILS REGARDING THE REPAIR, EXCEPT THE INFORMATION MENTIONED ABOVE. IN SUMMARY, THE FAULTY PART IS NO LONGER AVAILABLE FOR ARJO INSPECTION, SO IT WASS NOT POSSIBLE TO PERFORM ITS EVALUATION TO ESTABLISH, WHAT KIND OF FAULT LED TO THE ALLEGED INCIDENT. PLEASE NOTE THAT ACCORDING TO OPERATING AND PRODUCT CARE INSTRUCTIONS (IFU; 04.AL.00_4 DATED ON APRIL 2007) DELIVERED WITH THE DEVICE, EACH USER OF THE ARJO EQUIPMENT SHOULD FOLLOW THE INSTRUCTIONS FROM THE BOOKLET. IN CONNECTION WITH THE SUBJECT OF THIS INVESTIGATION, THE FOLLOWING WARNINGS WERE INCLUDED TO PREVENT FROM ANY INJURY OCCURRENCE (PAGE 5): "ALWAYS ENSURE THAT THE EQUIPMENT IS HANDLED BY TRAINED STAFF." "ALWAYS ENSURE THAT THE BATHERS' LIMBS ARE CLEAR OF THE DOOR BEFORE CLOSING." "ALWAYS KEEP FINGERS CLEAR OF THE DOOR WHEN CLOSING." THE IFU ALSO PROVIDES USER WITH PROPER DOOR USAGE INSTRUCTIONS THAT SHOULD BE FOLLOWED TO AVOID MALFUNCTION AND EVENT OCCURRENCE: "NEVER RECLINE THE BATH UNLESS THE DOOR IS IN THE CLOSED POSITION" "ALWAYS FIT LEG REST ON OPPOSITE SIDE OF BATH TO DOOR. IF HUNG ON THE DOOR - DAMAGE TO THE DOOR WILL OCCUR." PLEASE NOTE THAT IN SEPTEMBER 2015 ARJO PERFORMED THE LIFE CYCLE TEST FOR THE PARKER GAS STRUT (PH0355). THE TEST RESULTS REVEALED THAT IT IS NOT POSSIBLE TO UNSCREW GAS SPRING FROM PIVOT KNUCKLE DURING NORMAL USAGE, IF GAS SPRING IS ASSEMBLED ACCORDING TO SPECIFICATION AND IF THE GAS SPRING IS REPLACED AFTER 3 YEARS OF WORK AND REPLACED ACCORDING TO IFU. THE REVIEW OF REPORTABLE EVENTS WITH THE INVOLVEMENT OF THE PARKER BATH IN LAST YEARS REVEALED A LIMITED NUMBER OF SIMILAR INCIDENTS. IN SUMMARY, ACCORDING TO THE CUSTOMER ALLEGATION, THE DOOR GAS STRUT FAILED AND LED TO DOOR FALLING RESULTING IN HEAD INJURY OF CAREGIVER. THE BATHTUB WAS USED FOR A PATIENT HYGIENE AT THE TIME OF EVENT. BASED ON THE COLLECTED INFORMATION ABOUT THE MALFUNCTION THE DEVICE WAS NOT UP TO THE MANUFACTURER'S SPECIFICATION. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITIES DUE TO THE INFORMATION ABOUT MALFUNCTION, WHICH LED TO THE INJURY OCCURRENCE.