MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. PHOX ULTRA COOX; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH,

Model Number	42013
Medical Device Problem Code	Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse event or patient impact was reported.Investigation ongoing.
Event or Problem Description
On (b)(6) 2019: customer reported low na and high cl results for a patient in emergency department using a nova phox ultra coox analyzer when compared to the laboratory reference analyzer.
Additional Manufacturer Narrative
The dhr reviews were performed including an assessment of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications.During the service visit by nova technical support improper maintenance of instrument was discovered, the pump tubing was improperly attached at a waste bulkhead and pco2 cap had a small leak.The insufficient reference flow is the most probable root cause for low na and high cl results reported by the customer.The analyzer operated as intended once repairs were performed.The root cause is attributed to an operator error due to improper maintenance.Comparison study data obtained at the user facility was found to be comparable between the reference method, and another phox ultra analyzer.Moreover, the linearity testing shows that the phox ultra analyzer, sn (b)(4), performs as intended.The discrepant na and cl results could not be reproduced during linearity testing.

• Brand Name: PHOX ULTRA COOX
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH,
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• MDR Report Key: 8680648
• Report Number: 1219029-2019-00017
• Device Sequence Number: 2232939
• Product Code: JGS
• UDI-Device Identifier: 00385480420136
• UDI-Public: 00385480420136
• 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,Followup
• Report Date (Section B): 06/07/2019

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: 05/19/2019
• Supplement Date Received by Manufacturer: 05/19/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1