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

Model Number FGO MLAB8 SPIROMETER

Device Problem Electrical Shorting (2926)

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

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A vyaire technical support reviewed the information given by the customer and found that the unit has a defective electrical component.Unit will be sent to vyaire failure analysis laboratory for further evaluation.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It is reported to vyaire medical that the microlab spirometer experienced a burnt pc board and a non-functioning lcd.There was no patient involved with the reported issue.

• Brand Name: MICROLAB
• Type of Device: SPIROMETER, DIAGNOSTIC
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97204 ; GM 97204
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, CA 60045 ; 8333273284
• MDR Report Key: 10841313
• MDR Text Key: 217701662
• Report Number: 9615102-2020-00115
• Device Sequence Number: 1
• Product Code: BZG
• UDI-Device Identifier: 54250892905551
• UDI-Public: (01)54250892905551
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGO MLAB8 SPIROMETER
• Device Catalogue Number: 36-ML3500 MK8-STK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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