MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ PEDIATRIC NON-HEATED CIRCUIT, 4 FT DUAL LIMB W/ DRY GAS AND PRESSURE LI; VENTILATOR BREATHING CIRCUIT, SINGLE-USE

Model Number CIRCUIT RESP PED 4FT UNHTD 20/CS

Device Problem Failure to Disconnect (2541)

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

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, it was confirmed that the customer changed the circuit to prevent patient injury/harm.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 water trap was difficult to remove from the 9076-701 circuit resp ped 4ft unhtd 20/cs.The event occurred during use.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

H3: a video was provided from the customer for the investigation.Vyaire's investigation team could see the infant circuit that had the rigid water trap was difficult to disassemble.Therefore, the defect reported by the customer was confirmed.Since the physical sample is required to perform an investigation, a root cause could not be determined at this time.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56, if additional information becomes available.

Manufacturer Narrative

Vyaire medical's investigation team was able to confirm the reported issue.When the investigation team attempted to disassemble the water trap it was hard to seperate the body float water trap and the tank float water trap.Therefore, a quality notification was sent to the supplier of both components for further investigation.No defects were found on the sample received and the root cause of the failure was undetermined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56, if additional information becomes available.

• Brand Name: AIRLIFE¿ PEDIATRIC NON-HEATED CIRCUIT, 4 FT DUAL LIMB W/ DRY GAS AND PRESSURE LI
• Type of Device: VENTILATOR BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 686561-550
• MDR Report Key: 15831524
• MDR Text Key: 303997119
• Report Number: 8030673-2022-00281
• Device Sequence Number: 1
• Product Code: BZE
• 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: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CIRCUIT RESP PED 4FT UNHTD 20/CS
• Device Catalogue Number: 9076-701
• Device Lot Number: 0004223224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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