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

Model Number INFANT FLOW SIPAP

Device Problem No Pressure (2994)

Patient Problem No Information (3190)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 determine yet.

Event Description

The customer reported to vyaire that the sipap device would not build up any pressure.At this time, there is no information regarding patient involvement associated with the event.

Manufacturer Narrative

Result of investigation: the suspect device has been returned for evaluation, and the technician was able to verify the reported failure as pressure values were only around 3.3-3.5 cmh2o at a flow of 8 lpm.Evaluation also revealed pinholes on the flow meter outlet line.After replacing the affected tubes and verifying tightness, pressure values are now within range.The unit then underwent calibration, performance verification, and electrical safety test with no issues.Therefore, root cause has been determined to be leak in the internal tubing.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9639957
• MDR Text Key: 187719171
• Report Number: 2021710-2020-11293
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446063592
• UDI-Public: (01)10846446063592(11)20160226
• Combination Product (y/n): N
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 06/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1