MAUDE Adverse Event Report: NOMOLINE ISA CO2; OXIMETER

Model Number	800101
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection found no damage.The module was able to obtain readings with a sampling line and no errors were present.When no gas mixture was applied the module measurements were acceptable.When a gas co2 gas mixture was applied the device provided readings outside of the accuracy specification.A zero calibration of the module was performed and the measured value remained outside of specification.The pump would not run consistently compared to a known good module resulting in high readings.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported a results/readings issue.No patient impact or consequences were reported.

• Brand Name: NOMOLINE ISA CO2
• Common Device Name: OXIMETER
• MDR Report Key: 11784975
• Report Number: 3011353843-2021-00107
• Device Sequence Number: 17028178
• Product Code: CCK
• UDI-Device Identifier: 07350046131781
• UDI-Public: 07350046131781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: Health Professional
• Device Model Number: 800101
• Device Catalogue Number: 9921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2019
• 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