MAUDE Adverse Event Report: VYAIRE MEDICAL ASSY TURBINE MANIFOLD SERVICE REPL; NOT AVAILABLE

Model Number ASSY TURBINE MANIFOLD SERVICE REPL

Device Problem Mechanical Problem (1384)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported to vyaire medical that a whining sound was coming from the turbine manifold assembly and it was also getting hot.There was no patient involved in this event as it occurred during out-of-box.

Manufacturer Narrative

Vyaire file identification: (b)(4).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.

• Brand Name: ASSY TURBINE MANIFOLD SERVICE REPL
• Type of Device: NOT AVAILABLE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 15958494
• MDR Text Key: 307694135
• Report Number: 2021710-2022-17012
• Device Sequence Number: 1
• Product Code: BZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASSY TURBINE MANIFOLD SERVICE REPL
• Device Catalogue Number: 22051-001
• Device Lot Number: K1QP6-0000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1