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

Model Number INFANT FLOW LP GENERATOR/NASAL PRONGS

Device Problems Disconnection (1171); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

Vyaire medical reference number (b)(4).Vyaire medical received the suspect device, a lp infant flow generator, for evaluation.Upon completion of the device evaluation, a follow-up report will be submitted.

Event Description

The customer reported that the exhaust tubing disconnected while the device was in use on a patient.The patient required manual (b)(6) pressure ventilation.The customer inspected the tubing and noticed it appeared too large and did not have a proper seal.

Manufacturer Narrative

Device evaluation: results of investigation: vyaire medical received the suspect device, a infant flow lp generator/nasal prongs, and evaluated the device.An evaluation of the device duplicated the reported issue and isolated the issue to manufacturing operator error.A device history record review was performed and no issues were found.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 7454709
• MDR Text Key: 106301413
• Report Number: 8030673-2018-00421
• Device Sequence Number: 1
• Product Code: BZD
• 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,other,use
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

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 LP GENERATOR/NASAL PRONGS
• Device Catalogue Number: 7772020LP
• Device Lot Number: 0001191799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention