MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS® INFANT FACE MASK SIZE 2; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number VITAL SIGNS® INFANT FACE MASK SIZE 2

Device Problem Defective Component (2292)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/08/2021

Event Type  Injury  

Event Description

The customer reported that the vital signs® infant face mask size 1 and 2 ring was deflated when removed from the bag.Sample was pulled to use in emergent situations, deflation causes delay in patient care.As an intervention, the clinicians had to get syringe and fill mask with air before being able to rescue ventilate child.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not 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 customer reported that the vital signs® infant face mask size 1 and 2 ring was deflated when removed from the bag.Sample was pulled to use in emergent situations, deflation causes delay in patient care.As an intervention, the clinicians had to get syringe and fill mask with air before being able to rescue ventilate child.

• Brand Name: VITAL SIGNS® INFANT FACE MASK SIZE 2
• 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, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13023260
• MDR Text Key: 285673411
• Report Number: 8030673-2021-00225
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752132979
• UDI-Public: (01)10190752132979(10)0004178351
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAL SIGNS® INFANT FACE MASK SIZE 2
• Device Catalogue Number: 6810EU
• Device Lot Number: 0004178351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• 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
• Patient Outcome(s): Required Intervention