EARLYVUE VS30 VITALS MONITOR

Additional Manufacturer Narrative

THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: AT THE BENCH, THE BENCH TECHNICIAN STATED THAT THE RIGHT SPEAKER IS FAULTY. THEY POWERED THE UNIT OFF, OPENED THE UNIT, AND REMOVED THE RIGHT SPEAKER. THEN REMOVED THE LEFT AND RIGHT SPEAKERS AND SWAPPED POSITIONS AND POWERED THE UNIT BACK ON AND BOTH SPEAKERS WERE FAULTY. SWAPPED THE SPEAKERS BACK AND THE LEFT SPEAKER IS OPERATIONAL AND THE RIGHT SPEAKER DOES NOT WORK. IT WAS DETERMINED THAT BOTH SPEAKER ASSEMBLY AND MAIN BOARD IS TO BE ORDERED TO REPLACE THE ISSUE. THE BENCH TECHNICIAN INSTALLED NEW SPEAKERS AND MAIN BOARD, AND THE DEVICE WAS WORKING CORRECTLY AGAIN. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE SPEAKER AND MAINBOARD. THE REPORTED PROBLEM WAS CONFIRMED. AFTER PARTS WERE REPLACED, THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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

PHILIPS RECEIVED A COMPLAINT ON THE EARLYVUE VS30 VITALS MONITOR IS SHOWING SPEAKER MALFUNCTION ALARM MESSAGE. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF EVENT, NO PATIENT INVOLVEMENT.