MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VMAX ENCORE 22; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number	VMAX ENCORE 22
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: pc-(b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It is reported to vyaire medical that the vmax encore 22 experienced a burning smell from the dell computer.The customer confirmed that there was no patient involvement associated with the reported event.

• Brand Name: VMAX ENCORE 22
• Common Device Name: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 22745 savi ranch pkwy; yorba linda IL 92887
• MDR Report Key: 12455143
• Report Number: 2021710-2021-14501
• Device Sequence Number: 4067101
• Product Code: BTY
• UDI-Device Identifier: 10190752164260
• UDI-Public: (01)10190752164260(11)20181026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K942211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: VMAX ENCORE 22
• Device Catalogue Number: 777404-101
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1