MAUDE Adverse Event Report: VYAIRE MEDICAL PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 1200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The event trace contains no unusual alarm types or incident counts.All event trace entries are consistent with normal ventilator operation.The alarm entry codes found in the event trace all fall into what are considered non-critical alarm conditions.These alarms are typical alarms that normally occur during patient ventilation.The reported problem was not reproducible.The vent passed 120 hour extended tests at customer's settings with no unusual alarms or conditions occurring.Vent passed troubleshooting final test which includes many alarm and ventilation functions.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that the lap top ventilator 1200 works fine for about 5-10 min or so and then it starts auto-cycling and giving different alarms.The customer confirmed that there is no patient involvement associated with this reported event.

• Brand Name: PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• MDR Report Key: 12643813
• Report Number: 2021710-2021-14675
• Device Sequence Number: 1296107
• Product Code: CBK
• UDI-Device Identifier: 00845873002696
• UDI-Public: (01)00845873002696(11)20160322
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: LTV 1200
• Device Catalogue Number: 18888-201-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1