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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL MICROLAB; SPIROMETER, DIAGNOSTIC
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VYAIRE MEDICAL MICROLAB; SPIROMETER, DIAGNOSTIC Back to Search Results
Model Number FGO MLAB8 SPIROMETER
Medical Device Problem Code Electrical Shorting (2926)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/13/2020
Type of Reportable Event Malfunction
Additional 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 or Problem 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.
 
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Brand Name
MICROLAB
Common Device Name
SPIROMETER, DIAGNOSTIC
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
MDR Report Key10841313
Report Number9615102-2020-00115
Device Sequence Number11491515
Product Code BZG
UDI-Device Identifier54250892905551
UDI-Public(01)54250892905551
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K141936
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/14/2020
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 NumberFGO MLAB8 SPIROMETER
Device Catalogue Number36-ML3500 MK8-STK
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/14/2020
Initial Report FDA Received Date11/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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