Description of Event or Problem · 0
THIS LETTER IS TO INFORM YOU OF AN EVENT THAT OCCURRED AT (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2020 BETWEEN 16:25 AND 17:10 IN BED (B)(6). IT WAS REPORTED TO GE HEALTHCARE (GEHC) ON (B)(6) 2020 THAT A PATIENT EXPIRED, AND SPO2 LOW ALARMS WERE NOT BROADCASTED ON THE CONNEXALL NURSE CALL ALARM NOTIFICATION SYSTEM. THE CONTACT INFORMATION FOR (B)(6) HOSPITAL IS AS FOLLOWS: (B)(6). THE PATIENT WAS ALSO BEING MONITORED ON A GEHC DASH BEDSIDE PATIENT MONITOR NETWORKED TO A GEHC CIC CENTRAL STATION AT THE TIME OF THE EVENT. IT WAS NOTED THAT THE PATIENT WAS ONLY BEING MONITORED FOR THE SPO2 PARAMETER ON THE GEHC DEVICES. THE CUSTOMER DID NOT ALLEGE THAT THE GEHC DEVICES MALFUNCTIONED NOR WAS IT ALLEGED THAT THE GEHC DEVICES CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. HOWEVER, THEY REQUESTED THAT A REVIEW OF THE GEHC DEVICE LOG FILES BE PERFORMED. GEHC ENGINEERING ANALYZED THE CIC CENTRAL STATION LOG FILES WHICH SHOWED THAT MULTIPLE ALARMS WERE ASSERTED INCLUDING SPO2 LO, RATE LO AND SPO2 PROBE. THESE ALARMS WERE BROADCASTED ON THE DASH AND CIC AT WARNING-LEVEL FOR WHICH THERE ARE BOTH AUDIBLE AND VISUAL NOTIFICATIONS. THE VOLUME AT THE CIC WAS CONFIGURED TO 80%. GEHC CONCLUDED THERE WAS NO INDICATION OF A GEHC DEVICE MALFUNCTION. FROM THE INFORMATION AVAILABLE TO GEHC, CONNEXALL WAS ALSO INFORMED OF THE EVENT BY THE CUSTOMER. FORMAL FINDINGS FROM THE CONNEXALL INVESTIGATION WERE NOT SHARED WITH GEHC. THE CUSTOMER ALSO DECLINED TO SHARE DETAILS REGARDING HOW THE CONNEXALL ALARM NOTIFICATION SYSTEM IS CONNECTED TO THE GEHC MC NETWORK. GEHC SHARED WITH LOG REVIEW FINDINGS WITH THE CUSTOMER AND THERE IS NO INDICATION THEY HAVE REQUESTED ANY FURTHER ASSISTANCE WITH RESPECT TO THE REPORTED PATIENT EVENT. THE CONNEXALL NURSE CALL ALARM NOTIFICATION SYSTEM IS MANUFACTURED BY CONNEXALL. GEHC NOTIFIED CONNEXALL OF THE EVENT ON (B)(6) 2020. PER THE WEBSITE, THEIR CONTACT INFORMATION IS: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).