SYSTEM 2000
Received Oct 21, 2019 · Event occurred Aug 4, 2019
Report 3007420694-2019-00171 · MDR key 9213152
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Death
- Death
Narrative
Additional Manufacturer Narrative
ARJO WAS NOTIFIED BY FRENCH NATIONAL COMPETENT AUTHORITY (ANSM) ABOUT THE EVENT WITH INVOLVEMENT OF SYSTEM 2000 (RHAPSODY) BATH. IT WAS REPORTED THAT A PATIENT DIED DURING USE OF THE BATHTUB. OTHER INFORMATION INCLUDED IN THE REPORT REFERRED TO THE REQUEST FOR TRAINING. NO FURTHER DETAILS HAVE BEEN PROVIDED TO DATE. IT SHOULD BE UNDERLINED THAT ARJO WAS NOT INFORMED ABOUT THE INCIDENT DIRECTLY BY THE CUSTOMER FACILITY. THE FIRST NOTIFICATION WAS DELIVERED BY (B)(6) ON (B)(6) 2019, AFTER OVER TWO MONTHS FROM THE INCIDENT OCCURRENCE DATE ((B)(6) 2019). ARJO REPRESENTATIVE MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER FACILITY, BUT THE REQUESTED INFORMATION WAS NOT PROVIDED AND THE DEVICE WAS NOT MADE AVAILABLE FOR EVALUATION. DUE TO THE LIMITED DATA, WE WERE NOT ABLE TO ESTABLISH A ROOT CAUSE OR ANY CONNECTION BETWEEN THE DEVICE AND THE EVENT OR THE EVENT'S OUTCOME. IN SUMMARY, ACCORDING TO THE GATHERED INFORMATION THE SYSTEM 2000 BATH WAS USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT. THE LINK BETWEEN THE DEVICE AND THE ALLEGED INCIDENT WAS NOT ESTABLISHED. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, HENCE NO MALFUNCTION COULD HAVE BEEN IDENTIFIED. THIS EVENT WAS DECIDED TO BE REPORTED TO REGULATORY AUTHORITIES DUE TO ALLEGATION OF A PATIENT DEATH AND CLAIMED INVOLVEMENT OF THE ARJO DEVICE IN THE EVENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ON-GOING AND ADDITIONAL INFORMATION WILL BE PROVIDED IN THE NEXT REPORT.
Description of Event or Problem
ARJO WAS NOTIFIED ABOUT THE EVENT WITH INVOLVEMENT OF SYSTEM 2000 BATH. IT WAS REPORTED THAT A PATIENT DIED DURING USE OF THE BATHTUB. ACCORDING TO THE RECEIVED INFORMATION THE CARE UNIT HAS REQUESTED A TRAINING. NO FURTHER INFORMATION WAS MADE AVAILABLE TO DATE.