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

Model Number 36-ML3535 MK8-STK

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2019

Event Type  malfunction  

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 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.

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
• Type of Device: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9151983
• MDR Text Key: 166163675
• Report Number: 9615102-2019-00110
• Device Sequence Number: 1
• Product Code: BZG
• UDI-Device Identifier: 54250892905469
• UDI-Public: (01)54250892905469(11)20170105
• Combination Product (y/n): N
• PMA/PMN Number: K141936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 36-ML3535 MK8-STK
• Device Catalogue Number: 36-ML3500 MK8-STK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1