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 Pressure Problem (3012)

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

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.

Event Description

It was reported to vyaire medical that the peep (positive end-expiratory pressure) of infant flow sipap was unstable even though the flow was constant.The issue occurred during patient-use and the device was replaced with another ventilator.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Result of investigation: a vyaire service technician went on site and could not reproduce any error.The unit was tested and working fine.

• 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: 11665772
• MDR Text Key: 245400102
• Report Number: 2021710-2021-13712
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10846446063592
• UDI-Public: (01)10846446063592(11)20120514
• Combination Product (y/n): N
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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: 27476-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention