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

Model Number INSTRUMENT ASSY V62J AUTOBX

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 289902781
• Report Number: 2021710-2022-15599
• Device Sequence Number: 1
• Product Code: BZG
• UDI-Device Identifier: 10846446021288
• UDI-Public: (01)10846446021288(11)20190911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1