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

Model Number 73319-HEL

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 333260331
• Report Number: 3010838917-2024-00098
• Device Sequence Number: 1
• Product Code: CCL
• UDI-Device Identifier: 10190752117181
• UDI-Public: (01)10190752117181(10)230167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other