SURESIGNS VS3 NBP, SPO2

Additional Manufacturer Narrative

D4 UNIQUE DEVICE IDENTIFIER (UDI): THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016; THEREFORE, NO UDI IS REQUIRED. (B)(6). A PHILIPS FIELD SERVICE SPECIALIST ASSISTED THE CUSTOMER REMOTELY AND INDICATED THERE IS A PROBLEM WITH THE NON-INVASIVE BLOOD PRESSURE (NIBP) PUMP TO BE CHANGED. 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.

Description of Event or Problem

IT WAS REPORTED THE OVERPRESSURE PROBLEM ALARM DOES NOT START, BUT THE OTHER ALARMS WORK NORMALLY. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

ANALYSIS WAS PERFORMED BY THE CUSTOMER WHICH INCLUDED TESTING WAS PERFORMED BY APPLYING AN OVERPRESSURE OF 400 MMHG IN MONITORING MODE. THE OVERPRESSURE ALARM DID NOT TRIGGER AS EXPECTED. AN ADDITIONAL CHECK WAS PERFORMED IN TECHNICAL MODE, THE PRESSURE VALVE WAS ALSO EXPECTED TO OPEN AUTOMATICALLY, BUT IT DID NOT. THE RESULTS OF THE ANALYSIS WERE THE NBP PUMP WAS LIKELY DEFECTIVE AND REQUIRED REPLACEMENT. A REPLACEMENT NBP PUMP WAS ORDERED AND SHIPPED TO THE CUSTOMER'S SITE TO RESOLVE THE ISSUE. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.