MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number INFANT FLOW SIPAP

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has 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

The customer reported that the infant flow sipap ventilator experienced having white, then black, then back to white screen repeatedly while running on a patient.As an intervention, unit was swapped.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Device evaluation: d9, g3, g6, h2, h3, h6 and h10 result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.Removed lcd cable and performed a closer visual inspection under microscope.Found that the continuity connection was poor.The installation of flat cable was most likely offset during installation causing an intermittent continuity connection.Therefore, root cause is confirmed.The cable assembly was replaced and the software version was updated to 2.10.The unit was tested,configured and the unit meets the factory service specifications.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11704210
• MDR Text Key: 246670163
• Report Number: 2021710-2021-13662
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10846446063486
• UDI-Public: (01)10846446063486(11)20170406
• Combination Product (y/n): N
• PMA/PMN Number: K031745
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFANT FLOW SIPAP
• Device Catalogue Number: 27416-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention