AVALON CL BASE STATION

Description of Event or Problem

IT WAS REPORTED THAT THE AVALON CL BASESTATION IS INTERMITTENTLY SWITCHING FROM NORMAL HEARTBEAT. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

THE PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER BIOMED WHO ADVISED THAT THE DEVICE WAS INTERMITTENTLY SWITCHING FROM A NORMAL HEARTBEAT. THE RSE TRIED TO CLARIFY THE CUSTOMER ALLEGATION AND REQUESTED ADDITIONAL INFORMATION FROM THE BIOMED. THE BIOMED STATED THAT THEY BELIEVED THERE WAS A TONE DIFFERENCE WHEN THE DEVICE SWITCHED TO A US SOUND BUT ALSO STATED THAT THE EVIDENCE OF ISSUE IS HARD TO GATHER. THE RSE ADVISED THE BIOMED TO GATHER FURTHER INFORMATION (I.E VIDEO, PHOTOS OF ISSUE) AND ALSO PROVIDED THE BIOMED THE BASE STATION MANUAL TO SEE IF ANYTHING IN THE MANUAL COULD POINT TO WHAT THEY ARE DESCRIBING. THE RSE ALSO SUGGESTED TO CHANGE THE SCALP ELECTRODE OR TRANSDUCERS (IN CASE OF DAMAGE) TO SEE IF WE CAN NARROW DOWN THE REPORTED ISSUE. CURRENTLY IT IS SUSPECTED THAT THE ISSUE IS A ONE-OFF EVENT. THE CUSTOMER WILL CALL BACK IF ADDITIONAL INFORMATION IS GATHERED AT NEXT EVENT. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # (B)(6).