EARLYVUE VS30 VITALS MONITOR

Additional Manufacturer Narrative

A BIOMEDICAL EQUIPMENT TECHNICIAN (BET) VISITED ONSITE AND CONFIRMED THE REPORTED PROBLEM. THE BET DETERMINED THE ISSUE WAS CAUSED DUE TO A DEFECTIVE SPO2 CABLE. THE CUSTOMER WILL ORDER THE REPLACEMENT SPO2 CABLE THEMSELVES. THE INVESTIGATION CONCLUDES 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

IT WAS REPORTED THAT, WHILE THE DEVICE IS ON, THE EARLY VUE VS30 VITALS MONITOR READS A FALSE SPO2 SATURATION RATE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

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.