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

Model Number CIRCUIT,INFANT SL,HTD CONTINUOUS-FLOW,CHAMBER

Device Problem Temperature Problem (3022)

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

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

H3: 81 other - 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

It was reported to vyaire medical that the humidifier was not heating due to a bent prong on airlife¿ infant single limb heated wire circuit kit.The reported issue occurred during patient use and the circuit was changed.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: AIRLIFE¿ INFANT SINGLE LIMB 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 vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 16908551
• MDR Text Key: 314973657
• Report Number: 8030673-2023-00317
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 10190752145122
• UDI-Public: (01)10190752145122(10)0004185830
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CIRCUIT,INFANT SL,HTD CONTINUOUS-FLOW,CHAMBER
• Device Catalogue Number: AH132
• Device Lot Number: 0004185830
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/12/2023
• 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