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

Model Number	LTV 1000
Medical Device Problem Codes	Mechanical Problem (1384); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device/component was not returned for evaluation.Therefore, no root cause could be determined.Furthermore, it was determined that the ltv had low battery and the end user resolved the issue.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
Event or Problem Description
The customer reported to vyaire medical that the lap top 1000 ventilator shut off while on patient during transport, but no harm associated with the reported event.The end users were not using an external battery pack and the assumption is the internal battery died.Furthermore, the customer confirmed that the unit got plugged in as soon as the user saw it was not charged.

• Brand Name: LTV 1000 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618 ; 7149227837
• MDR Report Key: 14750055
• Report Number: 2021710-2022-16213
• Device Sequence Number: 11331721
• Product Code: CBK
• UDI-Device Identifier: 00845873000203
• UDI-Public: (01)00845873000203(21)A03429
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LTV 1000
• Device Catalogue Number: 10130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2001
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown