MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	18888-001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3:02-the suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.
Event or Problem Description
It was reported to vyaire medical that there is a leak on the 02 blender side at the tubing of the lap top 1200 ventilator.The customer reported there was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Device evaluation: h10 results of investigation: vyaire medical received the device for evaluation.Visual inspection of the uut (unit under test) found no signs of damage or misuse.The uut was tested as received in a stand-alone unit to duplicate the failure.The o2 pressure sensor tubing was occluded at the sensor end, and the uut was connected to an o2 gas supply, with the o2 supplied it was found that the uut leaked from the fitting tube straight mini type.Removed and reinserted/reseated the tubing polyurethane 1/8 o.D retested leak test ¿ fail.Removed the tubing polyurethane and the fitting tube straight mini type and replaced it with a known good part.Connected the uut to the o2 gas supply and induced 50 psi.No leak.Performed leak test and passed.Closer inspection of the uuts fitting tube shows that the inner gasket/seal is damaged (photo taken) compared to a known good fitting tube where the inside circumference of the fitting sealing gasket is good (photo taken).Uut causing a leak from the tube fitting with a damaged inner sealing gasket.The reported complaint was duplicated, and the root cause of the leak was due to internal damage to the fitting tube straight mini type.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
The supplemental report has corrected the referenced device to the ventilator.Note that the udi-di has been identified but the udi-pi is not available as this information was not made available to vyaire medical.

• Brand Name: LTV 1200 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18314999
• Report Number: 2021710-2023-18512
• Device Sequence Number: 6784510
• Product Code: CBK
• UDI-Device Identifier: 00845873000364
• UDI-Public: (01)00845873000364
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2023

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: 18888-001
• Device Catalogue Number: 18888-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 06/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/22/2023; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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