PARKER BATH

Additional Manufacturer Narrative

ON 2018-MAY-12 ARJO WAS NOTIFIED ABOUT AN EVENT WITH THE INVOLVEMENT OF PARKER BATHTUB. THE CUSTOMER REPORTED THAT PARKER BATH WAS LEAKING. THE ARJO SERVICE TECHNICIAN ATTENDED TO CUSTOMER FACILITY TO SOLVE THE REPORTED PROBLEM. DURING DEVICE INSPECTION, THE SERVICE TECHNICIAN IDENTIFIED THE DEFECT OF THE BATH'S DOOR GAS STRUT. THE MALFUNCTION RESULTED IN THE DOOR UNABLE TO REMAIN IN THE REQUIRED POSITION AND CLOSING FAST. THE DAMAGED PART WAS REPLACED AND DISPOSED OF AFTER REPAIR. THE CUSTOMER HAS NOT NOTICED THAT DOOR MALFUNCTION OCCURRED IN THE CUSTOMER FACILITY: (B)(6) . NO INFORMATION REGARDING AN INJURY OCCURRENCE WAS PROVIDED. THE ARJO TECHNICIAN FIXED THE DEFECTIVE PART THEN THE DEVICE HAS BEEN RETURNED TO USE. PLEASE NOTE THAT OPERATING AND PRODUCT CARE INSTRUCTIONS FOR PARKER BATHTUB (IFU; 04.AL.00_3 GB DATED ON NOVEMBER 2005) CONTAINS INFORMATION: "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 THE 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 THE OPPOSITE SIDE OF THE BATH TO DOOR. IF HUNG ON THE DOOR - DAMAGE TO THE DOOR WILL OCCUR.". THE IFU ALSO REMINDS THE CUSTOMER TO CHECK THE OPERATION OF THE DOOR REGULARLY ON A WEEKLY BASIS TO DETECT ANY FAILURE RELATED TO THIS ASSEMBLY. IN SECTION PREVENTIVE MAINTENANCE SCHEDULE IT ALSO INFORMS THAT THE DOOR STRUT SHOULD BE REPLACED AFTER 3 YEARS OF FUNCTIONING. ACCORDING TO THE HISTORY OF SERVICES FOR CLAIMED SERIAL NUMBER, THERE WAS FOUND COMPLAINT REGARDING REPLACEMENT OF A GAS STRUT IN 2018. PLEASE NOTE THAT FAULTY PART WAS NOT AVAILABLE FOR FURTHER EVALUATION. DUE TO THIS FACT, THE ROOT CAUSE IS IMPOSSIBLE TO DEFINE. IN SUMMARY, ACCORDING TO THE GATHERED INFORMATION, THE DOOR GAS STRUT FAILED AND RESULTED IN DOOR FALLING. THE FAILURE WAS FOUND DURING DEVICE INSPECTION PERFORMED BY ARJO SERVICE TECHNICIAN. THE DEVICE WAS NOT UP TO THE MANUFACTURER'S SPECIFICATION. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION DUE TO THE INFORMATION ABOUT MALFUNCTION (DOOR FALLING), WHICH COULD HAVE LED TO THE INJURY OCCURRENCE AND LACK OF INFORMATION INDICATING CIRCUMSTANCES IN WHICH THE MALFUNCTION WAS DETECTED.

Additional Manufacturer Narrative

PLEASE NOTE THAT THE VALUE ENTERED INTO DATE OF REPORT. DATE OF THIS REPORT' IN THE INITIAL REPORT WAS INCORRECT AS THE INITIAL REPORT WAS SUBMITTED ON(B)(6)2019. THE INFORMATION COLLECTION AND INVESTIGATION ARE ON-GOING. THEREFORE THE FINAL CONCLUSION IS NOT YET AVAILABLE. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN THE NEXT REPORT.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN THE NEXT REPORT.

Description of Event or Problem

ARJO WAS REQUESTED FOR A SERVICE OF THE PARKER BATH. UPON VISIT AT THE CUSTOMER FACILITY AND THE EVALUATION THE ARJO QUALIFIED REPRESENTATIVE FOUND THAT THE DOOR WILL DROP WHEN LET GO DUE TO UNSCREWED TOP OF THE GAS STRUT. THE CUSTOMER WAS UNAWARE OF THE ISSUE. THE DEVICE WAS REPAIRED AND PUT BACK TO USE. NO INJURY OR ADVERSE EVENT OCCURRENCE WAS REPORTED.