MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STAT PROFILE PRIME PLUS; SODIUM TEST SYSTEM

Model Number	Prime Plus
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The damaged board from the analyzer was returned to nova for investigation.The investigation concluded that there was damage to the power connector attached to this board.This damage is consistent with a downward "tug" on the connector.A dhr was performed on the whole prime analyzer and the board and no discrepancies were found.
Event or Problem Description
Customer reported that when the prime plus analyzer was plugged in there was a burning smell and the screen remained black.

• Brand Name: NOVA STAT PROFILE PRIME PLUS
• Common Device Name: SODIUM TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13965873
• Report Number: 1219029-2022-00032
• Device Sequence Number: 14494060
• Product Code: JGS
• UDI-Device Identifier: 00385480574006
• UDI-Public: 00385480574006
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200403
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: Prime Plus
• Device Catalogue Number: 57400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown