MAUDE Adverse Event Report: VYAIRE MEDICAL ETCO2 CANNULA 10', ADULT, MALE, 25/CSX; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	ETCO2 CANNULA 10', ADULT, MALE, 25/CSX
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the nasal cannula is not staying in the patient's nose causing inaccurate carbon dioxide (co2) reading.They had to tape the nasal cannula on the patients nose to get accurate readings.Furthermore, the customer confirmed there was no harm done to the patient.
Additional Manufacturer Narrative
Result of investigation: the device history record of the part number 2812m10-25 with lot number 0004245572 was reviewed and no issues were found.Based on the investigation per one opened physical sample of (b)(4).With no lot number we cannot confirm the reported defect.Customer reported that prongs part number 12278104 were too short and don't stay on the patient's nose.The physical sample was dimensionally tested according to rmqas 65-4243a etal and it was found acceptable and within specification.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: ETCO2 CANNULA 10', ADULT, MALE, 25/CSX
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra velancia ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 18576175
• Report Number: 8030673-2024-00371
• Device Sequence Number: 15679292
• Product Code: CCK
• UDI-Device Identifier: 10190752157262
• UDI-Public: (01)10190752157262(10)004245572
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ETCO2 CANNULA 10', ADULT, MALE, 25/CSX
• Device Catalogue Number: 2812M10-25
• Device Lot Number: 004245572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/22/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown