MAUDE Adverse Event Report: VYAIRE MEDICAL INC REVEL; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	19260-001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: the reported complaint was verified and duplicated.This is isolated to incorrect maintenance and device misuse with the 3 screws on the o2 inlet port which were not torqued to specifications and the damaged o-ring causes the leak from the o2 blender module.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 revel ventilator is coming in due to leak around the o2 connection.Customer tried multiple hoses with no success.No patient harm.
Additional Manufacturer Narrative
H3: disposition - revel, english service repair p/n:19260-001-99 s/n:(b)(6) will be moved to factory service.Assy, o2 module w-neb ferrite to be replaced.Replace material as required, rework to current configuration, recalibrate, and retest per specifications and standards.
Event or Problem Description
Additional information received indicates that the ventilator was returned and evaluated in the fa lab.The reported complaint was verified and duplicated.This is isolated to incorrect maintenance and device misuse with the 3 screws on the o2 inlet port which were not torqued to specifications and the damaged o-ring causes the leak from the o2 blender module.

• Brand Name: REVEL
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 19594072
• Report Number: 3013421741-2024-00215
• Device Sequence Number: 3980875
• Product Code: CBK
• UDI-Device Identifier: 10190752157071
• UDI-Public: (01)10190752157071(11)230713
• Combination Product (Y/N): N
• PMA/510(K) Number: K070594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 19260-001
• Device Catalogue Number: 19260-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown