SURESIGNS VS3 NBP, SPO2

Additional Manufacturer Narrative

D4: PRODUCT UDI - THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016, THEREFORE NO UDI. ANALYSIS WAS PERFORMED BY A PHILIPS BIOMEDICAL ENGINEER (BMED) WHICH INCLUDED INTERVIEWING THE CUSTOMER AND GOING ONSITE TO EVALUATE THE UNIT. ONCE ONSITE, THE BMED DISCOVERED THE DEFAULT SETTING WAS SET TO ADULT WHEN IT SHOULD HAVE BEEN SET TO PEDIATRICS BY STAFF MEMBERS. THE UNIT WAS PLACED OUT OF SERVICE UNTIL THE SETTINGS WERE CORRECTED BY THE BMED. ONCE THE BMED CHANGED THE DEFAULT SETTINGS, THE ISSUE WAS RESOLVED. BASED ON THE INFORMATION AVAILABLE IN THE CASE, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE THE DEFAULT SETTINGS SET BY STAFF MEMBERS. THE REPORTED PROBLEM WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ALL CUFFS CONSISTENTLY PRODUCED INCORRECT BLOOD PRESSURE READINGS AND REQUIRE QUALITY CONTROL. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.