CITADEL PATIENT CARE SYSTEM

Description of Event or Problem

ARJO WAS INFORMED ABOUT AN INCIDENT INVOLVING CITADEL PATIENT CARE SYSTEM. ACCORDING TO THE INFORMATION PROVIDED, PATIENT HEARD A "POP" SOUND, THE MATTRESS DEFLATED AND BED LOWERED ON ITS OWN. THERE WAS NO INJURY REPORTED. THE RENTAL TECHNICIAN VISITED THE CUSTOMER'S SITE AND WAS UNABLE TO DIAGNOSE THE PROBLEM, BOTH BED AND MATTRESS SEEMED TO BE IN GOOD WORKING CONDITION. THE SYSTEM WAS RETURNED TO SERVICE UNIT FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

THE BED AND MATTRESS WERE TESTED IN ACCORDANCE WITH THE PRODUCT'S SERVICING DOCUMENT. THE SCENARIO COULD NOT BE DUPLICATED. ALL BED AND MATTRESS FUNCTIONS WORKED CORRECTLY. THE REVIEW OF PREVIOUS COMPLAINTS REVEALED THAT IF NO COMPONENT FAILURE IS DETECTED, THE BED'S MOVEMENT MAY BE CAUSED BY THE UNINTENTIONAL ACTIVATION OF THE BUTTONS ON THE CONTROL PANEL. THIS HYPOTHESIS COULD NOT BE CONFIRMED DUE TO ITS NATURE. A LOCKOUT BUTTON LOCATED AT ATTENDANT CONTROL PANEL CAN BE USED TO PREVENT ACCIDENTAL ACTIVATION OF THE BUTTONS RESPONSIBLE FOR THE BED PLATFORM MOVEMENT. ACCORDING TO INSTRUCTIONS FOR USE DEDICATED TO CITADEL BED (830.213-EN REV.14): ¿LOCK-OUTS FOR BED FUNCTIONS SHOULD BE USED AT STAFF¿S DISCRETION TO PREVENT UNINTENTIONAL OPERATION OF BED.¿ BASED ON THE ABOVE FINDINGS, IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED UNINTENDED MOVEMENT. TO SUM UP, NO BED OR MATTRESS FAILURE THAT COULD CONTRIBUTE TO THE REPORTED MOVEMENT WAS FOUND. THE ARJO DEVICE DID NOT MEET ITS SPECIFICATION AS ALLEGEDLY THE MATTRESS DEFLATED AND BED MOVED WITHOUT ANY BUTTONS BEING PUSHED. THE SYSTEM WAS USED BY A PATIENT DURING THE EVENT. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO ALLEGATION OF THE UNINTENDED BED MOVEMENT.