PARKER BATH

Additional Manufacturer Narrative

ARJO WAS INFORMED ABOUT AN ISSUE INVOLVING PARKER BATH. IT WAS REPORTED THAT DURING INSPECTION THE DOOR GAS STRUT WAS MISSING, WHAT MAKES THE DOOR UNABLE TO STAY IN INTENDED UP- POSITION. THE BATHTUB WAS STILL USED BY THE CUSTOMER FACILITY DESPITE ITS CONDITION. IT REMAINS UNKNOWN WHY THE GAS STRUT WAS REMOVED FROM THE DEVICE. NO INJURY OCCURRENCE WAS REPORTED. THE BATHTUB WAS MANUFACTURED APPROXIMATELY 29 YEARS AGO AND IT WAS ADVISED TO THE CUSTOMER FACILITY TO REMOVE THE BATHTUB FROM USE DUE TO THE FOUND MALFUNCTION. THE ROOT CAUSE OF THE EVENT APPEARS TO BE RELATED TO INCORRECT MAINTENANCE OF THE DEVICE. PLEASE NOTE THAT IN THE CLAIMED MODEL OF PARKER BATHTUB THE GAS STRUT IS PLACED IN THE CLEARLY VISIBLE PLACE (ON THE BATHTUB'S SHELL). MOREOVER, THE LACK OF GAS STRUT AFFECTS FUNCTIONALITY OF THE DEVICE AND CAUSES SYMPTOM (DOOR NOT STAYING IN POSITION), WHICH IS VERY LIKELY TO BE NOTICED. TECHNICAL ADVISORY NOTICE THAT WAS INTRODUCED IN 2007 (TAN SE0607 ISSUED ON 2007-MAR-13) AND WAS DISTRIBUTED TO THE SALES AND SERVICE UNITS TO INFORM ABOUT IMPORTANCE OF NOTIFYING CUSTOMER THAT: "1. THE PM SCHEDULE STATES THAT AN ANNUAL INSPECTION FOR DAMAGES AND CHECKS OF THE DOOR LOCK AND DOOR OPERATION SHALL BE PERFORMED. THE ABOVE INCLUDES THE GAS STRUT AND THE ANCHORS TO VERIFY THAT: - THE GAS STRUT CAN KEEP THE DOOR STABLE AT HIGHEST POSITION (NO SIGN OF DROPPING DOWN IS ALLOWED). 2. THE FACILITIES INTERNAL WORKING PROCEDURES SHOULD BE AMENDED TO INCLUDE THAT A PERSON SHOULD ALWAYS HOLD THE DOOR OPEN WHEN THE RESIDENT ENTERS OR EXITS THE BATH. (AS A TEMPORARY ACTION UNTIL AN INSPECTION HAVE BEEN CARRIED OUT). 3. CONTACT ARJO SERVICE FOR AN INSPECTION AND MAINTENANCE OF THE PARKER BATH ALTERNATIVE REPLACEMENT OF THE BATH DUE TO THE AGE OF THE PRODUCT." TAN INCLUDES ALSO PROCEDURE OF WEEKLY CHECKPOINT CONTROL - CLARIFICATION AND ADDED CHECK POINTS OF THE DOOR: "CHECK THAT THE GAS STRUT KEEPS THE DOOR STABLE AT HIGHEST POSITION (NO SIGN OF DROPPING DOWN IS ALLOWED). CHECK THAT THE DOOR IS NOT RAISING OR LOWERING TOO FREELY OR QUICKLY DURING CLOSING AND OPENING OF THE DOOR." IF OPERATING THE DOOR DOESN'T WORK AS INTENDED, USER SHOULD CONTACT WITH ARJO REPRESENTATIVE FOR SERVICE AND MAINTENANCE. IN ACCORDANCE TO THIS, DEVICE SHOULDN'T BE USED WITH PATIENTS. THE REVIEW OF REPORTABLE EVENTS WITH THE INVOLVEMENT OF THE PARKER BATH IN LAST YEARS, DID NOT REVEAL ANY SIMILAR INCIDENT. IN SUMMARY, THE BATHTUB DOOR WAS FALLING AND IT WAS UNABLE TO REMAIN IN OPEN POSITION. THE TECHNICAL EVALUATION REVEALED THAT THE GAS STRUT WAS MISSING, SO THE DEVICE WAS NOT ACCORDING TO THE MANUFACTURER'S SPECIFICATION. THE BATHTUB WAS STILL USED BY THE CUSTOMER FACILITY DESPITE ITS MALFUNCTION, BUT NO SPECIFIC EVENT WAS REPORTED. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO COMPETENT AUTHORITY DUE TO ALLEGATION THAT BATH DOOR WAS FALLING AND THE BATHTUB WAS NOT REMOVED FROM USE BY THE CUSTOMER FACILITY.

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 CONCLUSION.

Description of Event or Problem

ARJO WAS INFORMED ABOUT AN ISSUE INVOLVING PARKER BATH. IT WAS REPORTED THAT DURING INSPECTION THE DOOR GAS STRUT WAS MISSING, WHICH ALLOWED THE DOOR TO FREE FALL AND NOT STAY IN ANY DESIRED POSITION. THE BATHTUB WAS USED BY THE CUSTOMER FACILITY. NO INJURY OCCURRENCE WAS REPORTED. THE BATHTUB WAS MANUFACTURED APPROXIMATELY 29 YEARS AGO AND IT WAS ADVISED THE CUSTOMER FACILITY TO REMOVE THE BATHTUB FROM USE DUE TO THE FOUND MALFUNCTION.