MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ADULT HEATED WIRE CIRCUIT KIT; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number AIRLIFE¿ ADULT HEATED WIRE CIRCUIT KIT

Device Problem Connection Problem (2900)

Patient Problem Hypoxia (1918)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported that the device is discarded since it was used on a covid patient.However, the customer sent a photo of the device for evaluation.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 airlife¿ adult heated wire circuit kit experienced heated high flow water chamber separate from the metal plate from lot number cm20k12.The customer confirmed that the patient became hypoxic.Patient was placed on a non-rebreather mask until the heater chamber could be replaced.

• Brand Name: AIRLIFE ADULT HEATED WIRE CIRCUIT KIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a de la producci?n; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11112296
• MDR Text Key: 225276537
• Report Number: 8030673-2020-00141
• Device Sequence Number: 1
• Product Code: OFP
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIRLIFE¿ ADULT HEATED WIRE CIRCUIT KIT
• Device Catalogue Number: AH202
• Device Lot Number: CM20K12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• 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