EARLYVUE VS30 VITAL SIGNS MONITOR

Description of Event or Problem

PHILIPS RECEIVED A COMPLAINT ON THE EARLYVUE VS30 VITAL SIGNS MONITOR INDICATING THE SYSTEM HAS HIGH SATURATION READINGS. IT IS UNKNOWN IF THE DEVICE WAS IN USE, MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER 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.

Additional Manufacturer Narrative

DIAGNOSTIC/FUNCTIONAL TESTING WAS PERFORMED AT THE PHILIPS AUTHORIZED REPAIR FACILITY. RESULTS OF FUNCTIONAL TESTING INDICATE THAT THE DEVICE WORKED AS DESIGNED. THE DEVICE'S OXYGEN SATURATION WAS CHECKED AND WAS WITHIN THE ESTABLISHED VALUES.