MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM; MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number	42014
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field service went on-site.During analysis by nova field support, both reference unit and device in question reported drift errors for different parameters, but no pattern of errors exhibited.Calibrating unit fixed these errors.Initial inspection of units also revealed that reference tubing segment was not seated in reference pinch valve correctly.This tubing must be flossed into pinch valve in order for reference solution to be blocked effectively.All quality control solutions were found to be in specification.Unit is correlating well with main lab vista.No further troubleshooting or corrective maintenance required.Unit was returned to end user for use.
Event or Problem Description
Customer reported that electrolyte values are not matching lab reference analyzer results.No patient treatment or adverse event reported.

• Brand Name: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
• Common Device Name: MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st.; waltham MA 02454 3654
• MDR Report Key: 9317103
• Report Number: 1219029-2019-00063
• Device Sequence Number: 390677
• Product Code: JGS
• UDI-Device Identifier: 00385480420143
• UDI-Public: 00385480420143
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K110648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 42014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1