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

Model Number	LTV 1200
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that constant power loss occurred on the lap top ventilator 1200.At this time, there is no information regarding patient involvement associated with the reported event.
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.
Additional Manufacturer Narrative
Results of investigation: vyaire medical received the device for evaluation.Visual inspection of the unit under test (uut) found no visible defects, damage or contamination.With no external power connected the uut was powered on and the post and event trace were produced and the customer settings were recorded.A check of vent op/usage found the ventilator has 219.3 hours of operation.With the uut connected to external power it was observed that the charge status led initially flashed amber then changed to a steady on state.The uut was allowed to cycle in the customer settings for a period of 4 hours and was found to operate without alarms or discrepancies.The following tests were performed to verify the performance of the uut: vent check, chapter 2 ventilator checkout tests: alarm, display, control and leak, passing on all counts.Power checkout, chapter 9 final checkout test: battery level, battery duration and external power test, passing on all counts.Operation on the internal battery lasted 88 minutes.A review of the entire event trace (455 entries) found that the entries displayed the uut operation for the previous period of 12.3 hours, from 07/17/2023 to 09/08/2023.The event trace indicates that for all periods of operation that included an ext lst1 (e15) (power loss) alarm, the ventilator was started without external power connected.In these cases the logging of an ext lst1 (e15) event is functionally correct.In most cases the ventilator was operated on the internal battery for a period of 30 minutes or more before external power was connected.Since it is not known if the uut was left connected to external power to charge the internal battery between periods of use, it is not known if the uut was always started with a fully charged internal battery.For the entire period recorded in the event trace, there were 30 separate vent1 (e1) (start) events.Of those, 15 were periods when an ext lst1 (e15) occurred.In 5 of those 15 there were multiple occurrences (counts of 2 (c2) through counts of 5 (c5)).During 3 of the 15 periods the ventilator alarmed bat low1 (e13) and in 2 of those 3 the ventilator also alarmed bat mpt1 (e11).In all cases the ventilator was (re)connected to external power prior to resetting.In no case did the ventilator alarm ln vent1 (e 67) due to loss of power.The uut was tested and found to operate to specifications.The event trace review found the complaint of power loss errors to have been caused by the operator.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• 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: 17731287
• Report Number: 2021710-2023-18167
• Device Sequence Number: 5875145
• Product Code: CBK
• UDI-Device Identifier: 10190752115637
• UDI-Public: (01)10190752115637
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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: LTV 1200
• Device Catalogue Number: 18888-201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/26/2023
• 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