MAUDE Adverse Event Report: VYAIRE MEDICAL PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG); VENTILATOR, CONTINUOUS, FACILITY USE

Model Number PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)

Device Problem Connection Problem (2900)

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

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

Vyaire file identification: (b)(4).The suspect device is not available for return since the customer stated that at this time the pandemic is requiring them to keep all consumables on hand.However, they sent a photograph of the product for evaluation.

Event Description

The customer reported that the patient circuit w/o peep, 22 mm spu (10/pkg) experienced connection issue.The proximal pressure line had sheared off.The line was in no way touched before the failure.The customer confirmed that there was no patient harm associated with the reported event.The patient was removed from the circuit and hand ventilated.Placed on a different ventilator with a different circuit.

Manufacturer Narrative

Photo investigation: according to the photo investigation, there was damage of l-fitting port which could be caused by applying of external abnormal force during assembly process.The damage of l-fitting port was caused by mishandling of circuit products during the assembly process and the work instruction mwi-as-1064/b did not specify handling requirement on guiding the worker to transmit and handle the circuit during the process.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11183796
• MDR Text Key: 230337086
• Report Number: 8030673-2021-00145
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PATIENT CIRCUIT W/O PEEP, 22 MM SPU (10/PKG)
• Device Catalogue Number: 29657-001
• Device Lot Number: 203711
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention