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

Model Number LTV1150

Device Problem Mechanical Problem (1384)

Patient Problem Death (1802)

Event Date 08/18/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.

Event Description

The customer reported to vyaire medical that the ltv1150 was no alarms but there is witnesses that claim there was alarms.They claim a patient die on this ventilator and wants to request for a download.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, ca
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 17400 medina road suite 100; minneapolis, mn
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, ca ; 3273284
• MDR Report Key: 10498320
• MDR Text Key: 205869588
• Report Number: 2031702-2020-03662
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873002726
• UDI-Public: (01)00845873002726(11)20150925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2020

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
• Device Operator: Health Professional
• Device Model Number: LTV1150
• Device Catalogue Number: 18984-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/06/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Death