PARKER BATH

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING INSPECTION REQUESTED BY THE CUSTOMER FACILITY, THE ARJO QUALIFIED REPRESENTATIVE DETECTED THE DEFECT OF THE BATH'S DOOR GAS STRUT. THE MALFUNCTION RESULTED IN THE DOOR UNABLE TO REMAIN IN THE REQUIRED UPRIGHT POSITION AND WAS CLOSING FAST. THE EVALUATION OF THE GAS STRUT REVEALED THAT IT IS SEPARATED AT THE BOTTOM, WHERE THE ROD IS ATTACHED TO THE PIVOT KNUCKLE. THE DAMAGED PART WAS REPLACED AND DISPOSED AFTER REPAIR. IT WAS CONFIRMED THAT THE BATHTUB WAS USED BY THE CUSTOMER DESPITE THE MALFUNCTION. NO INFORMATION REGARDING AN INJURY OCCURRENCE WAS PROVIDED.THE DEVICE WAS NOT UNDER THE ARJO SERVICE AGREEMENT AND REPAIRS WERE PERFORMED UPON THE CUSTOMER REQUEST. ON 2015-JUL-29 THE ARJO TECHNICIAN PERFORMED AN INSPECTION AND REPAIR OF THIS BATHTUB. IT WAS FOUND THAT THE DOOR GAS STRUT WAS DAMAGED BY THE FACILITY'S RESIDENT. THE ARJO TECHNICIAN FIXED THE PART AND THE DEVICE WAS PUT BACK TO USE. ACCORDING TO THE HISTORY OF SERVICES PERFORMED BY ARJO QUALIFIED PERSONNEL NO OTHER REPAIR WAS RELATED TO GAS STRUT MALFUNCTION.PLEASE NOTE THAT ACCORDING TO OPERATING AND PRODUCT CARE INSTRUCTIONS (IFU; 04.AL.00_3 GB DATED ON NOVEMBER 2005) 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."THE IFU ALSO REMINDS THE CUSTOMER TO CHECK 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. IT WAS NOT POSSIBLE TO CONFIRM THAT PART WAS NOT REPLACED ACCORDING TO THE PREVENTIVE MAINTENANCE SCHEDULE. THE FAULTY PART WAS NOT AVAILABLE FOR FURTHER EVALUATION.IN SUMMARY, ACCORDING TO THE GATHERED INFORMATION, THE DOOR GAS STRUT FAILED AND RESULTED IN DOOR FALLING. THE BATHTUB WAS USED BY THE CUSTOMER DESPITE THE MALFUNCTION. 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

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. ARJO REPRESENTATIVE EVALUATED THE DEVICE IN QUESTION. THE GAS STRUT HEAD WAS LOOSE BECAUSE OF THE ABSENCE OF A LOCKNUT. THE GAS STRUT HEAD WAS DISASSEMBLED AND THE DOOR WAS COMPLETELY FREE, SO IT WAS CLOSING HEAVY. THE BATHTUB WAS NOT REMOVED FROM USE BY THE CUSTOMER FACILITY DESPITE THE PROBLEM. THE DEFECTIVE PART WAS REPLACED BY THE ARJO REPRESENTATIVE. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN THE NEXT REPORT.

Description of Event or Problem

IT WAS REPORTED THAT DURING INSPECTION REQUESTED BY THE CUSTOMER FACILITY, THE ARJO QUALIFIED REPRESENTATIVE DETECTED THE DEFECT OF THE BATH'S DOOR GAS STRUT. THE MALFUNCTION RESULTED IN THE DOOR UNABLE TO REMAIN IN REQUIRED POSITION AND CLOSING FAST. THE BATHTUB WAS USED BY THE CUSTOMER DESPITE THE MALFUNCTION. NO INFORMATION REGARDING AN INJURY OCCURRENCE WAS PROVIDED.

Additional Manufacturer Narrative

THE INFORMATION COLLECTION AND ANALYSIS FOR THE INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN THE NEXT REPORT.