MAUDE Adverse Event Report: VYAIRE MEDICAL LTV 2200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number LTV 2200

Device Problem Mechanical Problem (1384)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

A third party service technician went onsite and learned that the customer tested the ventilator on test lung and having bpm inaccuracy issue.Bpm setting of 12 but the actual bpm was measured 94.The service technician checked the ventilator and was not able to verify or duplicate the reported problem since the unit is working fine.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported to vyaire medical that the lap top ventilator 2200 unit was malfunctioning while on a patient.The patient showed whole-body cyanosis and the spo2 (oxygen saturation) went down to 41%.The patient was immediately removed from the ventilator and provided manual ventilation until complete transfer to a backup ventilator.

• Brand Name: LTV 2200 VENTILATOR
• Type of Device: 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: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11389248
• MDR Text Key: 233964249
• Report Number: 2021710-2021-13468
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTV 2200
• Device Catalogue Number: 22690-006
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention