SURESIGNS VSI - NBP/SPO2

Additional Manufacturer Narrative

REPORTING INSTITUTION PHONE #: (B)(6). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED INCONSISTENCIES IN SPO2 READINGS, SOMETIMES THE READINGS ARE HIGH AND SOMETIMES THEY ARE LOW. 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

SECTION B EVENT DATE WAS CORRECTED.. SECTION G DATE RECEIVED BY MFG (RFB) WAS CORRECTED.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTIONS CENTER (CCSC) FOR ASSISTANCE. PHILIPS REMOTE SUPPORT (RS) PROVIDED CUSTOMER A SERVICE REPAIR QUOTATION FOR THE REPLACEMENT OF THE SPO2 BOARD AND NBP PUMP ASSEMBLY. A SERVICE REPAIR QUOTATION HAS BEEN PROVIDED TO THE CUSTOMER. HOWEVER, THE CUSTOMER HAS NOT ACCEPTED THE QUOTATION FOR REPAIR. A SEARCH IN SALESFORCE FOUND NO FURTHER RELATED CALLS. THE DEVICE REMAINS AT THE CUSTOMER'S FACILITY. H3 OTHER TEXT : SEE H10.