PARKER BATH

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 UPON THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem

ARJOHUNTLEIGH WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF PARKER BATH, WHERE IT WAS REPORTED THAT DURING USE THE CAREGIVER PULLED DOWN THE DOOR TO CLOSE AND DOOR FELL ON THE CAREGIVER'S LEFT ARM. ACCORDING TO THE RECEIVED INFORMATION THE CAREGIVER'S ARM WAS SWOLLEN AND IT WAS COOLED WITH ICE TO REMOVE THE SWELLING. THE ARM ALSO HAD SOME SLIGHT SCRATCHES.

Additional Manufacturer Narrative

ON 2018-FEB-21 ARJOHUNTLEIGH REPRESENTATIVE WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF PARKER BATH, WHERE IT WAS REPORTED THAT AT THE TIME THE CAREGIVER PULLED DOWN A DOOR TO CLOSE IT, THE DOOR FELL ON THE CAREGIVER'S LEFT ARM. ACCORDING TO THE RECEIVED INFORMATION THE CAREGIVER'S ARM WAS SWOLLEN AND HAD SOME SLIGHT SCRATCHES. IT WAS COOLED WITH ICE TO REMOVE THE SWELLING AND NO OTHER TREATMENT WAS APPLIED. THE ARJOHUNTLEIGH REPRESENTATIVE VISITED THE CUSTOMER FACILITY ON 2018-FEB-16 TO PERFORM BATHTUB SCHEDULED MAINTENANCE, BUT NO INFORMATION ABOUT THE EVENT OCCURRENCE WAS PROVIDED BY CUSTOMER AT THIS TIME. INFORMATION REGARDING INCIDENT WAS PROVIDED VIA TELEPHONE CALL PERFORMED ON 2018-FEB-21. ACCORDING TO THE SERVICE REPORT FOR THE CARRIED OUT MAINTENANCE THE DOOR WAS FALLING WHEN PULLED DOWNWARDS. BASED ON THE VISUAL INSPECTION NO MALFUNCTION OF THE DOOR GAS STRUT (PART NUMBER: PH0355) WAS VISIBLE OUTSIDE OF THE PART, BUT INSIDE THE PART WAS BROKEN. THE GENERAL CONDITION OF THE DEVICE WAS FOUND TO BE SATISFACTORY BESIDE THE BROKEN DRAINAGE HOSE AS NO OTHER DEFECT WAS DETECTED. THE FAULTY PART WAS REPLACED DURING THE VISIT, TOGETHER WITH BROKEN HOSE, WHICH'S MALFUNCTION HOWEVER WAS NOT RELATED TO THE OCCURRED EVENT. BASED ON THE COLLECTED INFORMATION THE CLAIMED UNIT WAS UNDER ARJOHUNTLEIGH SERVICE CONTRACT AND LAST DEVICE MAINTENANCE WAS PERFORMED ON 2017-MAR-15. DURING THIS MAINTENANCE SERVICE ARJOHUNTLEIGH REPRESENTATIVE FOUND THAT THE SOLENOID VALVE WAS LEAKING AND ONE FOOT (TILT GLIDE; PF0706) WAS MISSING, THEREFORE THE REPAIR OF THE BATHTUB WAS PERFORMED TO RECTIFY THESE ISSUES. NO OTHER FAULT (LIKE GAS STRUT DEFECT) WAS FOUND. THE REVIEW OF SIMILAR REPORTABLE EVENTS WITH THE INVOLVEMENT OF THE PARKER BATH IN LAST 5 YEARS REVEALED THAT NUMBER OF EVENTS RELATED TO SITUATION WHERE THE DEFECTIVE DOOR GAS STRUT CONTRIBUTED TO EVENT OCCURRENCE IS VERY LOW. IN COURSE OF THE INVESTIGATION THE SERVICE RECORDS FOR THE INVOLVED DEVICE WERE REVIEWED AND IT WAS NOT CONFIRMED THAT GAS STRUT WAS EVER REPLACED. THE FAULTY PART WAS DISPOSED AFTER REPAIR AND NO PICTURES WERE AVAILABLE, SO IT WAS NOT POSSIBLE TO CHECK ITS MANUFACTURING DATA LIKE BATCH NUMBER OR PRODUCTION DATE. THEREFORE ITS DEFECT WAS MOST LIKELY A CONSEQUENCE OF THE NORMAL WEAR RESULTING FROM YEARS OF USAGE. PLEASE NOTE THAT OPERATING AND PRODUCT CARE INSTRUCTIONS (IFU; 04.AL.00/3 DATED ON NOVEMBER 2005) DELIVERED WITH THE DEVICE, INCLUDES INFORMATION WHICH EACH USER OF THE ARJOHUNTLEIGH EQUIPMENT SHOULD FOLLOW. IN CONNECTION WITH THE SUBJECT OF THIS INVESTIGATION, THE FOLLOWING WARNINGS WERE ESTABLISHED TO PREVENT FROM ANY INJURY OCCURRENCE: "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 OPCI ALSO REMINDS THE CUSTOMER TO CHECK OPERATION OF THE DOOR REGULARLY ON A WEEKLY BASIS TO DETECT ANY FAILURE RELATED TO THIS ASSEMBLY. PLEASE NOTE THE DOOR GAS STRUT SHOULD BE REPLACED EVERY 3 YEARS ACCORDING TO PREVENTIVE MAINTENANCE SCHEDULE DESCRIBED IN IFU ACTIVE AT THE TIME WHEN THIS DEVICE WAS MANUFACTURED. THE TECHNICIAN WHO WAS RESPONSIBLE FOR SERVICE OF THIS BATHTUB WILL BE INFORMED ABOUT CORRECT GAS STRUT REPLACEMENT INTERVALS TO MEET THE REQUIREMENTS. BASED ON THE COLLECTED INFORMATION AT THE TIME OF EVENT THE DEVICE DID NOT MEET MANUFACTURER SPECIFICATION DUE TO WORN DOOR GAS STRUT. IT WAS UNKNOWN IF, WHEN THE EVENT OCCURRED THE BATHTUB WAS USED FOR PATIENT HYGIENE AS ONLY THE CAREGIVER INVOLVEMENT WAS CONFIRMED. WE DECIDED TO REPORT THIS INCIDENT BECAUSE OF THE SUSTAINED AN INJURY.