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

Model Number INFANT FLOW SIPAP

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

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 determined yet.

Event Description

The customer reported to vyaire that the sipap device shows a failure (read manual message symbol) without error code, no alarm and it cannot build up pressure.There is no patient involvement associated with the event.

Manufacturer Narrative

The problem was that an internal tubing was kinked and therefore no pressure reading.This was fixed and a 2 year pm was performed in addition.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9747699
• MDR Text Key: 184318001
• Report Number: 2021710-2020-11429
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446004830
• UDI-Public: (01)10846446004830(11)20120928
• 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: 01/28/2020

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
• Device Operator: Health Professional
• Device Model Number: INFANT FLOW SIPAP
• Device Catalogue Number: 675-CFG-012
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1