MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM; BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER

Model Number	42013
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
Discrepant patient ph result on nova phox ultra coox analyzer.

• Brand Name: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
• Common Device Name: BLOOD GAS/ELECTROLYTE/METABOLITE/CO-OXIMETRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st.; waltham MA 02454 3654
• MDR Report Key: 9171679
• Report Number: 1219029-2019-00052
• Device Sequence Number: 19433832
• Product Code: CHL
• UDI-Device Identifier: 00385480420136
• UDI-Public: 00385480420136
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/08/2019

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: 42013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1