MAUDE Adverse Event Report: VYAIRE MEDICAL MICROLAB; SPIROMETER, DIAGNOSTIC

Model Number	36-ML3535 MK8-STK
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported the burning smell came from the electronics board.At this time, vyaire has not received the suspected component for evaluation.
Event or Problem Description
The customer reported burnt electronic board from the microlab-loop device.The customer reported the equipment began to smell like smoke and was identified by the technician through the burning smell.The customer reported there is no patient involvement associated with the event.
Additional Manufacturer Narrative
Results of investigation: the vyaire failure analysis lab received the suspected device/component and performed a failure investigation.The reported issue could not be evaluated in the laboratory setting due to the burnt component, making it impossible to evaluate.The device was repaired and the unit has passed all test, calibrations and is working to manufacture specifications.

• Brand Name: MICROLAB
• Common Device Name: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9151983
• Report Number: 9615102-2019-00110
• Device Sequence Number: 2131874
• Product Code: BZG
• UDI-Device Identifier: 54250892905469
• UDI-Public: (01)54250892905469(11)20170105
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K141936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 36-ML3535 MK8-STK
• Device Catalogue Number: 36-ML3500 MK8-STK
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1