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

Model Number	ENVE VENTILATOR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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
The customer reported failure to display fraction of inspired oxygen on the enve ventilator.At this time, there is no information regarding patient involvement associated with the reported event.
Additional Manufacturer Narrative
Results of investigation: vyaire received the device for evaluation.Service technician was able to duplicate customer reported problem that states failure to display fraction of inspired oxygen on ventilator during testing and evaluation.Further investigation found the fraction of inspired oxygen function was on a disabled mode preventing it from displaying the fraction of inspired oxygen value on the vent.Enabled the fraction of inspired oxygen function and the vent display the fraction of inspired oxygen value.Unit passed 120 hours of extended bench testing without error condition.Unit passed initial final and initial alarm volume test with no abnormalities or unusual alarm conditions.Vent was opened and inspected; no anomalies found.Process ventilator through service to meet all factory specifications and standards.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12643805
• Report Number: 2021710-2021-14778
• Device Sequence Number: 13777074
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20130422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENVE VENTILATOR
• Device Catalogue Number: 19250-001-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 10/16/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1