CITADEL PATIENT CARE SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. FURTHER INFORMATION WILL BE AVAILABLE IN THE NEXT EXPECTED REPORT.

Description of Event or Problem

ARJO WAS INFORMED ABOUT A PATIENT FELL FROM THE BED, WHILE ROTATING THE BED. ALL 4 SAFETY SIDES WERE UP DURING THE EVENT OCCURRED. NO INJURY WAS SUSTAINED. ALLEGEDLY, THE PATIENT WENT OVER THE LEFT SIDE RAIL WHILE IT WAS ROTATING. THE INSPECTION DID NOT CONFIRM ANY DEVICE MALFUNCTION.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL ONGOING. FURTHER INFORMATION WILL BE AVAILABLE IN THE FINAL REPORT.

Additional Manufacturer Narrative

IT WAS CLAIMED THAT THE PATIENT FELL OVER THE SIDE RAILS WHILE THE DEVICE WAS ROTATING. THE PATIENT DID NOT SUFFER ANY INJURIES. ACCORDING TO THE INFORMATION PROVIDED BY A FACILITY, ALL OF 4 BED¿S SAFETY SIDES WERE LOCKED IN THE UPRIGHT POSITION. THE PATIENT FELL OVER THE SIDE RAILS WHILE THE PATIENT TURNING FEATURE (NURSE ASSIST) WAS ACTIVATED. THE CUSTOMER DID NOT MENTION IN WHICH POSITION THE BED WAS PLACED DURING THE EVENT. THE PATIENT TURN FEATURE ON THE CITADEL PATIENT CARE SYSTEM IS A FUNCTION DESIGNED TO HELP CAREGIVERS SAFELY REPOSITION PATIENTS IN BED. IT WORKS BY INFLATING AIR BLADDERS BENEATH THE MATTRESS, GENTLY ROTATING THE PATIENT TO THE LEFT OR RIGHT BY APPROXIMATELY 20 DEGREES. THIS HELPS REDUCE THE NEED FOR MANUAL HANDLING. INSTRUCTIONS FOR USE (IFU) 830.238-EN REV 13 ¿ 2024-06 WARNS USERS ABOUT THE PROPER USAGE OF THE DEVICE TURNING FUNCTION: "TURNING - CAUTION: PRIOR TO ENGAGING ANY MATTRESS TURN FEATURE, MAKE SURE THAT BED FRAME HAS SIDE RAILS AND THAT ALL SIDE RAILS ARE FULLY ENGAGED IN THEIR FULL UPRIGHT AND LOCKED POSITION. DO NOT ACTIVATE THE TURNING FEATURE ON ANY MATTRESS SYSTEM WHEN PATIENT RESTRAINTS ARE IN USE". IFU INFORM USERS ALSO HOW THE PATIENT TURN (NURSE ASSIST) IS WORKING. "PATIENT TURN (NURSE ASSIST) - INFLATES BLADDERS UNDER THE MATTRESS TO PROVIDE PATIENT RIGHT OR LEFT ROTATION OF APPROXIMATELY 20°. AN AUDIBLE TONE WILL SOUND WHEN FULL ROTATION HAS BEEN ACHIEVED. IN ORDER TO ACTIVATE THIS FUNCTION, ALL SIDE RAILS MUST BE UP AND THE FOWLER ANGLE MUST BE LESS THAN 30°. IF A SIDE RAIL IS LOWERED IN THE DIRECTION OF THE PATIENT TURN OR THE FOWLER ANGLE IS INCREASED TO ABOVE 30°, THIS FUNCTION WILL BE CANCELED. PRESS THE PATIENT CENTER BUTTON TO CANCEL PATIENT TURN; THIS FUNCTION WILL NOT AUTOMATICALLY TIME OUT. PATIENT TURN IS NOT AVAILABLE WHEN FOWLER ANGLE IS ABOVE 30° OR ANY SIDE RAIL IS DOWN. IT IS RECOMMENDED THAT TURNING ONLY BE INITIATED WHEN BED IS LEVEL AND THIGH AND CALF SECTIONS ARE DOWN. THE ACTUAL ANGLE OF ROTATION ACHIEVED BY A PATIENT IS DEPENDENT ON MANY FACTORS INCLUDING: PATIENT WEIGHT, PATIENT WEIGHT DISTRIBUTIONS, PRESSURE SETTINGS AND PATIENT POSITIONING ON THE MATTRESS SURFACE. 20° IS THE TARGET TURN ANGLE BUT WILL NOT BE ACHIEVED BY ALL PATIENTS BASED ON THE VARIABLES MENTIONED ABOVE. IT IS POSSIBLE TO INTERRUPT PATIENT TURN WITH OTHER NURSE ASSIST FUNCTIONS. AFTER DEACTIVATION OF THOSE FUNCTIONS, THE PREVIOUS THERAPY IS RESTARTED". IFU WARNS USERS THAT "ROTATION THERAPIES ARE NOT AVAILABLE WHEN FOWLER ANGLE IS ABOVE 30° OR ANY SIDE RAIL IS DOWN. IT IS RECOMMENDED THAT TURNING ONLY BE INITIATED WHEN BED IS LEVEL AND THIGH AND CALF SECTIONS ARE DOWN". THE SIMULATION WAS PERFORMED TO REPLICATED THE CLAIMED SCENARIO AND DETERMINED WHETHER BED COULD HAVE CONTRIBUTED TO THE ALLEGED PATIENT FALL, HOWEVER THE SCENARIO WAS NOT RECREATED. ADDITIONALLY, THE DISTANCE BETWEEN THE TOP OF THE SAFETY SIDE AND THE MATTRESS PLATFORM WAS MEASURED TO ENSURE THE BED IS COMPLIED TO THE APPLICABLE STANDARDS. THE DISTANCE WAS MEASURED AND IT WAS 10 INCHES, WHICH IS 252 MILLIMETERS. THAT HEIGHT IS COMPLY TO THE STANDARD. CITADEL PATIENT CARE SYSTEM IS CERTIFIED IN ACCORDANCE WITH THE IEC 60601-2-52 STANDARD, WHICH STATED THAT THE HEIGHT OF THE TOP EDGE OF THE SIDE RAIL ABOVE THE MATTRESS SHOULD BE AT LEAST 220 MILLIMETRES. ARJO DEVICE WAS USED FOR A PATIENT TREATMENT WHEN THE EVENT OCCURRED AND FROM THAT PERSPECTIVE IT PLAYED A ROLE IN THE EVENT. THE DEVICE WAS PERFORMING AS INTENDED. NO MALFUNCTION WAS FOUND DURING THE DEVICE EVALUATION. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO ALLEGATIONS THAT THE PATIENT FELL FROM THE BED PLATFORM WHILE THE TURNING ASSIST FUNCTION WAS ACTIVATED. NO INJURY WAS SUSTAINED.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL ONGOING. FURTHER INFORMATION WILL BE AVAILABLE IN THE FINAL REPORT.