MAUDE Adverse Event Report: VYAIRE MEDICAL OBS,INSTRUMENT ASSY V62J AUTOBX; SPIROMETER, DIAGNOSTIC

Model Number	INSTRUMENT ASSY V62J AUTOBX
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the vmax module had a burning smell coming from it.The issue occurred during the calibration portion of the dlco (carbon monoxide diffusing capacity).The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, the customer took apart the module and they could got a whiff of burning smell.They requested a replacement module and after the replacement everything is okay.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: OBS,INSTRUMENT ASSY V62J AUTOBX
• Common Device Name: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13722451
• Report Number: 2021710-2022-15599
• Device Sequence Number: 14799765
• Product Code: BZG
• UDI-Device Identifier: 10846446021288
• UDI-Public: (01)10846446021288(11)20190911
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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: INSTRUMENT ASSY V62J AUTOBX
• Device Catalogue Number: 773835-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown