AVALON PATIENT MODULE

Additional Manufacturer Narrative

A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON AN AVALON PATIENT MODULE INDICATING THAT THE DEVICE WAS NOT READING CORRECTLY. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

NO TESTING WAS DONE; HOWEVER, REMOTE SERVICE PERSONNEL PERFORMED REMOTE COMMUNICATION AND TROUBLESHOOTING WITH THE CUSTOMER BIOMED. THE CUSTOMER INDICATED THERE WAS A BRIEF DELAY IN MONITORING THE PATIENT'S HEARTRATE; HOWEVER, THE NURSING STAFF SWAPPED THE MODULE FOR ANOTHER TO RESOLVE THE ISSUE. BASED ON THE RESULTS OF THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS A FAULTY ECG/IUP MODULE. THE ISSUE WAS RESOLVED BY REPLACING THE MODULE. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS NECESSARY AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON AN AVALON PATIENT MODULE INDICATING THAT THE DEVICE WAS NOT READING CORRECTLY. IT WAS NOTED THAT THEY WERE NOT ABLE TO SUCCESSFULLY PERFORM DIRECT ECG FETAL HEARTRATE MEASUREMENT USING FETAL SCALP ELECTRODES. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.