EARLYVUE VS30 VITALS MONITOR

Additional Manufacturer Narrative

A PHILIPS REMOTE SERVICE ENGINEER (RSE) CONTACTED THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED). THE BIOMED RAN AN AUDIO TEST AND THE DEVICE WAS STILL SHOWING THE ERROR. THERE WAS NO SOUND, EVEN THOUGH THE VOLUME WAS SET TO SEVEN OUT OF TEN. THE BIOMED REQUESTED INFORMATION ON THE SPEAKER ASSEMBLY, AND ORDERED A NEW SPEAKER. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A FAULTY SPEAKER. THE REPORTED PROBLEM WAS CONFIRMED. THE CUSTOMER WAS PROVIDED PART INFORMATION ON A REPLACEMENT SPEAKER TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 VITALS MONITOR INDICATING THAT THERE WAS A SPEAKER MALFUNCTION ERROR AND THERE WAS NO SOUND. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.