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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION - SIZE 5 CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL VITAL SIGNS¿ ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION - SIZE 5 CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number 6850-VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2022
Event Type  malfunction  
Manufacturer Narrative
The customer did not sent pictures or the physical sample for the investigation, also we were unable to review the device history record since the lot number was not provided. Therefore; the defect reported by the customer was not confirmed. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that the 6850-vital signs® adult face mask with adjustable air cushion size 5 are not inflated well when he tries to inflate more air and it's not giving him a good seal. The customer mentioned that this could be a problem if he runs into a situation ventilating a patient. There was no patient involvement.
 
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Brand NameVITAL SIGNS¿ ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION - SIZE 5
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
VYAIRE MEDICAL
510 technology dr
irvine IL 92618
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada via de la produccion
no. 85, parque undustrial mex
mexicali,
MX
Manufacturer Contact
erika bonilla
510 technology dr
irvine, IL 92618
7149227837
MDR Report Key14741330
MDR Text Key301904912
Report Number8030673-2022-00252
Device Sequence Number1
Product Code CAI
UDI-Device Identifier10190752147461
UDI-Public(01)10190752147461
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 05/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6850-VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5
Device Catalogue Number6850
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? No
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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