MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. INFANT FLOW; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	7772000LP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Situation/primary concern: defect - vyaire infant flow generator ncpap.Background: rt was called to pt beside by rn to look at equipment.Pt is receiving nasal continuous positive airway pressure (ncpap) through the vyaire sipap machine.Rn noticed a hole in the expiratory limb of the infant flow tubing which was leaking water onto pt isolette bedding.Rt grabbed new infant flow generator kit from clean supply.When exchanging the flow generator, rt noticed two holes on the new flow generator expiratory limb as well.(lot: 0004262729) rt grabbed second flow generator kit with different lot number, and it had a hole in it as well.(lot: 0004240543).Rt confirmed that this is a manufacturing error and holes should not be in expiratory limb.This error does not effect pt ventilation or oxygenation.However, depending on where the holes are located, the water can leak out causing bedding to get wet and baby potentially getting cold.Recommendation: rt will place tape around expiratory limb hole.If leaking continues to be a problem, rt will exchange vyaire sipap for servo-u ventilator with flexi trunk ncpap.

• Brand Name: INFANT FLOW
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 20300704
• Report Number: 20300704
• Device Sequence Number: 7744954
• Product Code: BZD
• UDI-Device Identifier: 10190752152687
• UDI-Public: (01)10190752152687(11)23080
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024
• Report Date (Section F): 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7772000LP
• Device Catalogue Number: 7772000LP
• Device Lot Number: 0004240543
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/13/2024