MAUDE Adverse Event Report: VYAIRE MEDICAL, INC PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number ENVE VENTILATOR

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

Vyaire complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.Results of investigation: a vyaire certified service technician was able to verify the customer's reported issue.Bench testing revealed that the device fails post test due to the device seizing after powering up.Pt programming tools were used to check all the modules communication state.During this assessment, it was verified that o2 blender module fails to boot up and gives an operation failed message.This non-conforming o2 module can cause the vent to fail and create the reported issue.The service technician replaced the o2 module and the reported issue was resolved.The device passed all testing and met all vyaire manufacturer specifications.

Event Description

It was reported to vyaire that the enve ventilator can be powered up and that is all.The clinician was not able to do anything else after the ventilator was powered on.At this time, it is unknown if there was any patient involvement associated with the reported issue.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• 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: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7573761
• MDR Text Key: 110335540
• Report Number: 2031702-2018-02199
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070594
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENVE VENTILATOR
• Device Catalogue Number: 19250-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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