MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ ADULT HEATED WIRE; VENTILATOR BREATHING CIRCUIT, SINGLE-USE

Model Number AIRLIFE¿ ADULT HEATED WIRE

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

The customer reported that the airlife¿ adult heated wire circuit dual-limb, dual-heated circuit experienced circuits became flooded with water.The customer confirmed that there was no patient harm associated with the reported event.

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.

• Brand Name: AIRLIFE¿ ADULT HEATED WIRE
• Type of Device: VENTILATOR BREATHING CIRCUIT, SINGLE-USE
• 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: 12715860
• MDR Text Key: 280941668
• Report Number: 8030673-2021-00207
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 10190752145146
• UDI-Public: (01)10190752145146
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE¿ ADULT HEATED WIRE
• Device Catalogue Number: AH180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2021
• 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: Unknown
• Patient Sequence Number: 1