B7

Additional Manufacturer Narrative

ON (B)(4) 2018 ARJO WAS NOTIFIED ABOUT AN INCIDENT WITH INVOLVEMENT OF B7 BATH. IT WAS REPORTED THAT ON (B)(6) 2018 THE INTENSIVE MENTALLY HANDICAPPED RESIDENT WAS TRANSFERRED TO THE BATHTUB WITH USAGE OF THE LIFT AND THEN THE CAREGIVER LEFT THE BATHROOM. WHEN HE CAME BACK THE RESIDENT WAS FOUND UNCONSCIOUS. THE RESIDENT WAS HOSPITALIZED, BUT DIED ONE DAY LATER. NO INFORMATION ABOUT TREATMENT WAS PROVIDED TO DATE. THE BATHTUB WAS TAKEN OUT OF USE AND INSPECTED BY THE QUALIFIED ARJO REPRESENTATIVE ON 2018-DEC-19. IT WAS FOUND TO BE WORKING CORRECTLY AND IT WAS NOT POSSIBLE TO RECREATE THE INCIDENT OR DETECT ANY MALFUNCTION. ACCORDING TO THE INTERVIEW PERFORMED BY THE ARJO REPRESENTATIVE ON-SITE WITH THE FACILITY'S EMPLOYEES, IT WAS SUPPOSED THAT THE PATIENT DROWNED AS THERE WAS NO SUPERVISION OF THE CAREGIVER. THE LOCAL POLICE OFFICE WAS INVOLVED IN THE INVESTIGATION AND DID NOT POINT THE DEVICE ITSELF AS A CAUSE OF THE INCIDENT. PLEASE NOTE THAT EACH USER SHOULD FOLLOW THE GUIDELINES INCLUDED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). THIS EQUIPMENT SHOULD BE HANDLED BY THE TRAINED STAFF, WITH ADEQUATE KNOWLEDGE OF THE CARE ENVIRONMENT, ITS COMMON PRACTICES AND PROCEDURES. BASED ON THE COLLECTED INFORMATION THERE WAS NO DEFICIENCY WITHIN THE INVOLVED ARJO BATHTUB AND NO DIRECT RELATION (EXCEPT ITS USAGE AT THIS TIME) BETWEEN PRODUCT AND DEATH CAN BE ATTRIBUTED. THE PATIENT, WHO DIED WAS MENTALLY HANDICAPPED AND BECAUSE OF HIS CONDITION SHOULD NOT BE LEFT WITHOUT ASSISTANCE AND SUPERVISION. THEREFORE THIS EVENT IS CONSIDERED TO BE UNFORTUNATE INCIDENT TO WHICH MOST PROBABLY CONTRIBUTED THE CAREGIVER NOT ATTENDING THE PATIENT. THE REVIEW OF REPORTABLE EVENTS WITH THE INVOLVEMENT OF THE B7 BATH IN LAST YEARS DID NOT REVEAL ANY SIMILAR INCIDENT. IN SUMMARY, ACCORDING TO THE CUSTOMER ALLEGATION, THE PATIENT WAS FOUND UNCONSCIOUS DURING USAGE OF THE BATHTUB. HOWEVER, THE TECHNICAL EVALUATION DID NOT REVEAL ANY MALFUNCTION. THE BATH WAS USED FOR PATIENT HYGIENE AND IN THAT WAY IT PLAYED A ROLE IN THIS EVENT. THE INCIDENT WAS DECIDED TO BE REPORTED TO THE COMPETENT AUTHORITIES DUE TO THE INFORMATION THAT THE PATIENT DIED.

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. THE BATHTUB WAS INSPECTED BY THE QUALIFIED ARJO REPRESENTATIVE. IT WAS FOUND TO BE WORKING CORRECTLY AND IT WAS NOT POSSIBLE TO RECREATE THE INCIDENT OR DETECT ANY MALFUNCTION. ADDITIONAL INFORMATION WILL BE PROVIDED WITHIN THE NEXT REPORT.

Description of Event or Problem

ARJO WAS NOTIFIED ABOUT AN INCIDENT WITH INVOLVEMENT OF B7 BATH. IT WAS REPORTED THAT THE INTENSIVE MENTALLY HANDICAPPED RESIDENT WAS TRANSFERRED TO THE BATHTUB WITH USAGE OF THE LIFT AND THEN THE CAREGIVER LEFT THE BATHROOM. WHEN HE CAME BACK THE RESIDENT WAS FOUND UNCONSCIOUS. THE RESIDENT DIED ONE DAY LATER. NO INFORMATION ABOUT TREATMENT WAS PROVIDED TO DATE.