CARESCAPE B450

Additional Manufacturer Narrative

THE PATIENT WAS BEING MONITORED ON A CARESCAPE B450 BEDSIDE MONITOR NETWORKED TO A CSCS V3 CENTRAL STATION. IT WAS ALLEGED THAT THE CENTRAL STATION DID NOT AUDIBLY ALARM AS EXPECTED. GE HEALTHCARE'S INVESTIGATION FOUND THAT THE B450 WAS A LOANER DEVICE THAT HAD BEEN INSTALLED IN THE CUSTOMER'S ICU FOR USE WHILE THEIR OWN MONITOR WAS BEING REPAIRED. HOWEVER, THE B450 WAS INCORRECTLY CONFIGURED TO OR MODE INSTEAD OF ICU MODE. IN OR MODE CONFIGURATION, AUDIBLE ALARMS ARE NOT PROVIDED AT THE CENTRAL STATION (VISUAL ALARMS ARE STILL PRESENT). THE AUDIO AND VISUAL ALARMS AT THE B450 ARE UNAFFECTED. THE CSCS V3 USER MANUAL PROVIDES THE FOLLOWING WARNING: "AUDIO ALARMS WILL NOT SOUND AT THE CENTRAL STATION WHEN A BEDSIDE MONITOR IS CONFIGURED FOR USE IN OPERATING ROOMS." BASED ON THE INFORMATION AVAILABLE, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION THAT LED TO THE REPORTED ISSUE.

Additional Manufacturer Narrative

LEGAL MANUFACTURER: (B)(4). A1-2, 4-6: NOT PROVIDED BY THE CUSTOMER. GE HEALTHCARE'S INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT NO AUDIBLE ALARMS WERE PROVIDED WHEN THE PATIENT EXPIRED.