MAUDE Adverse Event Report: VYAIRE OY VITAL SIGNS; ANESTHESIA GAS SAMPLING LINE, DISPOSABLE, 3M/10FT

Model Number	73319-HEL
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the 73319-hel - gas sampling line, 10ft, m/m was partially occluded, causing the anesthesia machine to go into a check defend alarm status.Though there were half-hour delays during the surgery, the customer confirmed that there was no patient harm associated with the reported event.
Event or Problem Description
It was reported to vyaire medical that the 73319-hel - gas sampling line, 10 ft, m/m was partially occlkuded, causing the anesthesia machine to go into a check defent alarm status.Though there were half-hour delays during the surgery, the customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Complaint is not valid and was not confirmed.Investigation of the provided sample showed that the product used was not 73319-hel that the complaint was made against.

• Brand Name: VITAL SIGNS
• Common Device Name: ANESTHESIA GAS SAMPLING LINE, DISPOSABLE, 3M/10FT
• Manufacturer (Section D): VYAIRE OY; kuortaneenkatu 2; la-suomen laani; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): VYAIRE OY; kuortaneenkatu 2; qiao long district, tangxia; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18544347
• Report Number: 3010838917-2024-00098
• Device Sequence Number: 18106087
• Product Code: CCL
• UDI-Device Identifier: 10190752117181
• UDI-Public: (01)10190752117181(10)230167
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051092
• 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): 01/19/2024

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: 73319-HEL
• Device Catalogue Number: 73319-HEL
• Device Lot Number: 230167
• 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: 12/26/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown