EARLYVUE VS30 VITAL SIGNS MONITOR

Description of Event or Problem

IT WAS REPORTED THAT A SPEAKER FAILURE ALARM (INOP) WAS DISPLAYED ON THE EARLYVUE VS30 VITAL SIGNS MONITOR. A GOOD FAITH EFFORT WAS PERFORMED AND IT WAS CONFIRMED THAT SOUND / DIMINISHED SOUND WAS STILL AUDIBLE AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

Additional Manufacturer Narrative

DURING INVESTIGATION THE REPORTED PROBLEM TURNED OUT TO BE NOT REPORTABLE. EVEN THOUGH THERE WAS A VISUAL INOP, THE AUDIO HAS BEEN CONFIRMED TO WORK AND PROVIDES SOUND. DIAGNOSTIC/FUNCTIONAL TESTING WAS PERFORMED AT THE PHILIPS AUTHORIZED REPAIR FACILITY. RESULTS OF FUNCTIONAL TESTING INDICATE THAT THE MAINBOARD WAS DEFECTIVE. IT WAS CONFIRMED THAT A SPEAKER FAILURE APPEARED, BECAUSE THE CONNECTOR ON THE MAINBOARD WHERE THE SPEAKER IS CONNECTED WAS DAMAGED. THE MAINBOARD WAS REPLACED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE MAINBOARD. THE REPORTED PROBLEM WAS CONFIRMED. A REPLACEMENT OF THE MAINBOARD WAS PERFORMED TO RESOLVE THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

Description of Event or Problem

IT WAS REPORTED THAT A SPEAKER FAILURE ALARM (INOP) WAS DISPLAYED ON THE EARLYVUE VS30 VITAL SIGNS MONITOR. IT IS UNKNOWN IF SOUND WAS STILL COMING FROM THE DEVICE AT THE TIME OF THE INOP.IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

Additional Manufacturer Narrative

E1: (B)(6). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.