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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL INC. VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X -LARGE AD
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation. No root cause has been determined yet. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The product is available to be returned for investigation. Pictures are also attached. The customer reported to vyaire medical that the 6861- vital signs® extra large face mask with adjustable air cushion size 6x -large adult face mask, deflated while connected to a patient. The customer confirmed that there was no harm and there was no intervention needed.
 
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Brand NameVITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
VYAIRE MEDICAL INC.
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key12081210
MDR Text Key264985798
Report Number8030673-2021-00177
Device Sequence Number1
Product Code CAI
UDI-Device Identifier10190752147379
UDI-Public(01)10190752147379
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X -LARGE AD
Device Catalogue Number6861
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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