MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STATT PROFILE PRIME PLUS ANALYZER SYSTEM; BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM, PRODUCT CODE CHL

Model Number	54700
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant reported suspect error problems over the weekend of (b)(6) 2022 which resulted in a delay of care for a patient in the neonatal unit.
Additional Manufacturer Narrative
The analyzer was inspected by a sr.Regional field suppor specialist, the levey jennings chart was analyzed as well as a general inspection and system check.All qc was noted to be in range.Analyzer was operational.No issues found.A dhr review is currently in process.There was no reported sequelae as a result of the reported delay in treatment.

• Brand Name: STATT PROFILE PRIME PLUS ANALYZER SYSTEM
• Common Device Name: BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM, PRODUCT CODE CHL
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454
• Manufacturer Contact: rebecca figueira ; 200 prospect st; waltham, MA 02454 ; 7816473700
• MDR Report Key: 15033007
• Report Number: 1219029-2022-00044
• Device Sequence Number: 6943470
• Product Code: CHL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 54700
• Device Catalogue Number: 57400
• Device Lot Number: 22033020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown