MAUDE Adverse Event Report: VYAIRE MEDICAL 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	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The equipment was received in vyaire medical facility.A service technician verified the reported "internal leak" problem.Service technician performed circuit leak test and heard a leak while occluding the wye.Unit failed the test and gave a check for leaks message.It was seen that the diaphragm was improperly installed in the exhalation port.Replaced the diaphragm with a new one and passed the circuit leak test at 9.3 lpm.Root cause is the improperly installed diaphragm.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that enve ventilator have internal leak.As of this time, there is no information about patient involvement associated in this reported event.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11042194
• Report Number: 2021710-2020-13051
• Device Sequence Number: 19091034
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20130619
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 11/20/2020

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: 12/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1