MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+; BLOOD CHEMISTRY ANALYZER

Model Number	37413
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The customer reported they were receiving high pco2 values on their statprofile ccx +1 analyzer.The customer reported they input an offset for the pco2 calculation until they had time to perform maintenance on the analyzer.When maintenance was performed, they replaced the membrane.Upon replacing the pco2 membrane, the analyzer started producing expected results.Because troubleshooting was successfully performed by the customer, the facility is continuing to use the instrument; therefore no device is being returned for evaluation.There was no reported patient harm or intervention.A device history record (dhr) was initiated and completed by the investigator.The review included an assessment of the production, testing, and release of the product.No abnormalities or concerns were observed.The dhr indicated the released product met all specifications.Trending will be monitored for this and/or similar complaints.
Event or Problem Description
On february 22, the customer reported they were receiving high values for pco2 on their statprofile ccx +1, s/n (b)(4).The user reported the analyzer algorithm was adjusted until maintenance could be performed.The facility is continuing to use the instrument therefore it will not be returned for evaluation.There was no reported patient harm or intervention required.

• Brand Name: STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
• Common Device Name: BLOOD CHEMISTRY ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 11474090
• Report Number: 1219029-2021-00005
• Device Sequence Number: 11719879
• Product Code: CIG
• UDI-Device Identifier: 00385480374132
• UDI-Public: 00385480374132
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: No Information
• Device Model Number: 37413
• Device Catalogue Number: 37413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1