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	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The equipment was received in vyaire medical facility.A service technician verified the reported "touch screen is torn" problem.Vent passed the display check but failed the touch screen calibration.Service technician replaced the lcd display with a known good one and passed.It was determined that the root cause is the lcd display.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 touch screen is torn.As of this time, there is no information about patient involvement associated in this reported event.
Additional Manufacturer Narrative
Result of investigation: the reported complaint was able to be confirmed and duplicated.Found uut to be physically damaged with a torn touch screen assembly (p/n 13324-001 rev.02 touch screen assy, ptv) and a deeply scratch lcd display module (p/n 12746-001 rev.A assy, lcd module) due to improper handling.

• 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: 11183799
• Report Number: 2021710-2021-13214
• Device Sequence Number: 19827834
• Product Code: CBK
• UDI-Device Identifier: 00845873000005
• UDI-Public: (01)00845873000005(11)20131118
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/22/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1