MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STAT PROFILE PRIME PLUS ANALYZER SYSTEM; BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM

Model Number	PRIME PLUS
Medical Device Problem Codes	Smoking (1585); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Event or Problem Description
Nova biomedical corporate was made aware of a potential product malfunction using a statprofile prime plus benchtop analyzer, serial number (b)(4).It was reported the analyzer was producing a buring smell and smoke was coming from the machine.The analyzer was immediately taken out of service and removed from the facility.There was no impact on patient or user safety.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Event or Problem Description
Nova biomedical corporate was made aware of a potential product malfunction using a stat - profile prime plus benchtop analyzer, serial number (b)(6).It was reported the analyzer was producing a burning smell and smoke was coming from the machine.The analyzer was immediately taken out of service and removed from the facility.There was no impact on patient or user safety.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova biomedical is requesting additional information, and further details will be provided in a supplemental report.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Additional Manufacturer Narrative
Udi: (b)(4).The customer reported a burning smell and smoke was produced by a stat profile prime plus benchtop analyzer with serial number: (b)(6).This occurred on (b)(6) 2021.The analyzer did not indicate there was a problem.The customer indicated the analyzer was powered off and taken out of service immediately with no impact on patient care.The customer also indicated the power supply cable had been dropped the day prior to the incident which caused a mechanical strain on the analyzer.The distributor identified the circuit board which had caused the smoke and returned it to nova biomedical for investigation.The board was identified as not being the original part installed on the analyzer at the time of manufacture.A previous engineering change order required the placement of kapton tape over particular leads on the board to prevent potential electrical shorts with the metal chassis of the instrument.The returned board was void of this tape.Further investigation included testing multiple boards under different factors including mechanical stress and excessive heat.After these tests, the reported problem could not be reproduced when the kapton tape was present.Device history record (dhr) reviews were performed for the analyzer by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter and test strip batch.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be reproduced after testing the returned circuit board and the manufacturer retains of similar circuit boards.A conclusive root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.

• Brand Name: STAT PROFILE PRIME PLUS ANALYZER SYSTEM
• Common Device Name: BLOOD GASES (PCO2, PO2) AND BLOOD PH TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 1941
• Manufacturer Contact: samantha cox ; 200 prospect st; waltham, MA 02454-1941 ; 7816473700
• MDR Report Key: 12541450
• Report Number: 1219029-2021-00032
• Device Sequence Number: 11116747
• Product Code: CHL
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K193246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/30/2022

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
• Device Model Number: PRIME PLUS
• Device Catalogue Number: 57400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 08/30/2021; 10/24/2021; 10/24/2021; 01/06/2022; 03/24/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/28/2021; 11/24/2021; 12/23/2021; 01/21/2022; 03/29/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown