MAUDE Adverse Event Report: VYAIRE MEDICAL INC. LTV 1000 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	LTV 1000
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical 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.
Event or Problem Description
The customer reported device shut down while on a transport on the lap top ventilator 1000.The customer reported there was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire received the device for evaluation.Visually inspected unit under test.Found several paints chipped like cosmetic damages on the front weldment.Device was connected onto a known good ac adapter and powered on.Device passed post test with no issues.Uut then underwent ventilator check and passed alarm test, display test, button test & leak test" with no issues.A further review of device event trace log and troubleshooting determined that the reported issues was caused by failed internal battery.With the removal of the external a/c power while device cycling, device will shut down logging the ln vent1 entries due device to switching over to the failed internal battery power.A known good test battery was then installed unto device and an external a/c power was connected.The external power light emitting diode illuminated solid green with charge status illuminated flashing amber for 60 seconds, then solid amber indicating the that test battery was being charge accordingly.Device was able to be ran on test battery power with no issues.Device was then warmed up to 103.4°f and then connected onto a known good circuit and a known good test lung and cycle onto ventilation using the customer setting device was received with.Using gas / flow analyzer listed, the tidal volume was measured.The reported complaint was able to be confirmed and duplicated.Reported failure caused by a failed internal battery vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LTV 1000 VENTILATOR
• 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: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13640498
• Report Number: 2021710-2022-15640
• Device Sequence Number: 16697552
• Product Code: CBK
• UDI-Device Identifier: 00845873000203
• UDI-Public: (01)00845873000203(11)20030115
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K051767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 02/01/2022

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 1000
• Device Catalogue Number: 10130-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2003
• 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