MAUDE Adverse Event Report: SOFTECH CO2 SAMPLING CANNULA P, 7FT 7FT, M; ANALYZER, GAS, CARBON-DIOXIDE,

Model Number	IPN914295
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the etc02 cannula works for about 20 minutes and after this time it doesn't measure the value of c02 any more".No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site (shengyurui medical - soundway) for investigation.Soundway reports "in the middle of august, we received the sample sent back by mail from the customer.After our inspection and testing of the sample, we found that the sample was normal and the functional test met the technical specifications." the complaint could not be confirmed.
Event or Problem Description
It was reported that "the etc02 cannula works for about 20 minutes and after this time it doesn't measure the value of c02 any more".No patient harm or injury reported.Patient condition reported as "fine".

• Brand Name: SOFTECH CO2 SAMPLING CANNULA P, 7FT 7FT, M
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE,
• MDR Report Key: 12245504
• Report Number: 3011137372-2021-00194
• Device Sequence Number: 3223059
• Product Code: CCK
• UDI-Device Identifier: 14026704657985
• UDI-Public: 14026704657985
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K143469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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 Expiration Date: 11/01/2024
• Device Model Number: IPN914295
• Device Catalogue Number: 2851
• Device Lot Number: 191088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1