HEMOSPHERE

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. D2B. ADDITIONAL DEVICE PRODUCT CODE: DQK, QAQ, MUD, DXN, DSB, QMS, FLL.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE, THE OXIMETRY CABLE DISPLAYED INACCURATE VALUES. WHEN CONNECTED AND FOLLOWING ALL RECOMMENDED TROUBLESHOOTING STEPS, THE DEVICE CONSISTENTLY DISPLAYED A READING OF 5. THE ISSUE PERSISTED DESPITE TROUBLESHOOTING EFFORTS. THERE WAS NO ALLEGATION OF PATIENT INJURY REPORTED.