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

Model Number LTV 1150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Distress (2329)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Any additional information provided by the customer will be included in a follow up report.Results of investigation: a vyaire certified service technician determined that there were no issues nor faults with the suspect device.The device passed 305 hour extended tests at customer¿s settings without any unusual alarms and conditions.The device also passed the automated final test which includes many ventilation and alarm functions.The event trace contained no unusual alarm types or incident counts.All event trace entries are consistent with normal ventilator operation.The device passed all testing and met all vyaire manufacturer specifications.

Event Description

It was reported to vyaire that a patient using model lap top ventilator 1150 was frequently being hospitalized.The hospital was looking at unintentional neglect on the patient's mother's part.The hospital believes that since he did not have night nursing, he was not supervised throughout the night and would be in distress by the morning.The mother began to blame everything including the ventilator so the hospital requested vyaire to perform noninvasive testing.The hospital confirmed that there are no reports of the ventilator malfunctioning or allegations from the hospital's staff.

• Brand Name: LTV 1200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 17400 medina road; suite 100; plymouth MN 55447
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7087862
• MDR Text Key: 93881542
• Report Number: 2031702-2017-02020
• Device Sequence Number: 1
• Product Code: CBK
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: LTV 1150
• Device Catalogue Number: 18984-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2008
• 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): Hospitalization