MAUDE Adverse Event Report: VYAIRE MEDICAL MICROLAB MK8 WITH SPCS SOFTWARE; SPIROMETER, DIAGNOSTIC

Catalog Number 36ML3500SMK8R2AND3

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).The suspect device has not been returned for evaluation.Therefore, no root cause could be determined.However, the technical support informed the customer that we do not repair units and they are just swapped out.The customer was sent a quote for purchase.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Event Description

It was reported to vyaire medical that the microlab unit is getting hot and not charging.There was no patient involvement associated with the reported event.

• Brand Name: MICROLAB MK8 WITH SPCS SOFTWARE
• Type of Device: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, ; GM
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13971999
• MDR Text Key: 298214984
• Report Number: 9615102-2022-00122
• Device Sequence Number: 1
• Product Code: BZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141936
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 36ML3500SMK8R2AND3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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