MAUDE Adverse Event Report: VYAIRE MEDICAL INC. EXHAUST LINE WITH COLDER; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Model Number EXHAUST LINE WITH COLDER

Device Problem Leak/Splash (1354)

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

Event Date 11/21/2023

Event Type  malfunction  

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.

Event Description

It was reported to vyaire medical that the 8004463 exhaust line with colder was leaking.There was no patient harm reported.

• Brand Name: EXHAUST LINE WITH COLDER
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): A&G LTD.; kadaka tee 46; tallinn 12915 ; EN 12915
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18271100
• MDR Text Key: 330040403
• Report Number: 3010838917-2023-00093
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EXHAUST LINE WITH COLDER
• Device Catalogue Number: 8004463
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1