MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 1150 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	M2M ASSY,LTV1150,WITH ACCESS.ENGLISH
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the a battery failure has occurred on the ltv 1150 ventilator which eventually shut down during patient use.It was stated that the unit was not even charging.Furthermore, the patient was transferred to another device and there was no patient harm associated with the event.
Additional Manufacturer Narrative
Result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported complaint could not be duplicated or confirmed.The uut (unit under test) was received at the fa lab without proper packaging.

• Brand Name: LTV 1150 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: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 17222701
• Report Number: 2021710-2023-17867
• Device Sequence Number: 7206744
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K101643
• 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
• Report Date (Section B): 06/28/2023

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: M2M ASSY,LTV1150,WITH ACCESS.ENGLISH
• Device Catalogue Number: 18984-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 11/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown