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

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.

• Brand Name: VITAL SIGNS¿ ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION - SIZE 5
• Type of Device: CIRCUIT, 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 Key: 14741330
• MDR Text Key: 301904912
• Report Number: 8030673-2022-00252
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752147461
• UDI-Public: (01)10190752147461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6850-VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5
• Device Catalogue Number: 6850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• 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
• Patient Sequence Number: 1