HEMOSPHERE

Description of Event or Problem

AS REPORTED, DURING USE IN PATIENT, A HEMOSPHERE MONITOR WAS ON DEMO MODE FOR A NIGHT WITH A FLOTRAC SENSOR AND OXIMETRY CATHETER. ALTHOUGH "DEMO MODE" WAS DISPLAYED ON THE MONITOR, THE PHYSICIAN WHO PERFORMED CALIBRATION DID NOT REALIZE THAT IT WAS DEMO MODE. ON THE NEXT MORNING, THE NURSE NOTICED IT WAS DEMO MODE AS THE WAVEFORM DID NOT BECOME FLAT BY OPENING THE VENT PORT TO THE ATMOSPHERE WHEN ATTEMPTED TO ZERO THE FLOTRAC SENSOR. THE BLOOD PRESSURE WAVEFORM HAD BEEN MONITORED CORRECTLY WITH A PATIENT MONITOR. AS OF THE AFTERNOON ON (B)(6), PATIENT WAS DOING WELL. IT IS UNCLEAR WHETHER THE PATIENT WAS TREATED BASED ON THE VALUES DISPLAYED ON DEMO MODE. HOWEVER, ACCORDING TO THE CLINICAL ENGINEER, ALTHOUGH BASIC VITAL SIGNS WERE MAINLY OBSERVED/MONITORED, CARDIAC OUTPUT (CO) DISPLAYED ON DEMO MODE WAS ALSO LIKELY USED AS A REFERENCE SINCE THEY WERE IN MEDICAL CHART. THIS IS NOT A REPORT OF DEVICE ERROR. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

ADDITIONAL FDA PRODUCT CODES: DQE, DQK, MUD, DXN, DSB, QMS, FLL, OLW. THE DEVICE IS NOT AVAILABLE FOR RETURN. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. WITH THE PROVIDED SERIAL NUMBER, THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCE'S. IF THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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.

Additional Manufacturer Narrative

FURTHER INVESTIGATION WAS COMPLETED ON THE EVENT. PER THE EVENT DESCRIPTION, IT WAS DESCRIBED THAT THE USER DID NOT REALIZE THE DEVICE WAS IN DEMO MODE. THIS SUGGESTS THAT THERE WAS A USE ERROR FOR NOT FOLLOWING INSTRUCTION AS DEMO MODE SHOWS A VISUAL INDICATOR ON THE MONITOR THAT THE DEVICE IS IN DEMO MODE. THE ALLEGATION IS MAINLY TO ADDRESS THAT THE USER WAS NOT AWARE OR MISSED THE VISUAL INDICATOR AND IS NOT AN ALLEGATION OF THE DEVICE MALFUNCTION. DESPITE THAT INFORMATION, DEVICE WAS NOT RETURNED TO CONFIRM THE ISSUE OR TO PERFORM A ROOT CAUSE INVESTIGATION.