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 Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2020

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 medical that sipap device has cannot setup flow on sipap, therefore no peep possible.There is no patient involvement associated with the event.

Manufacturer Narrative

Result of investigation: the technician evaluated the suspect device and was able to confirm the reported failure.It was due to the left and right flow meter buttons being not properly attached.They had loosened further while turning.After repair, suspect device was then calibrated and checked according to manufacturer's specifications.Electrical safety test was also carried out.

• 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: 9863834
• MDR Text Key: 187721253
• Report Number: 2021710-2020-11543
• 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: 02/21/2020

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: 02/21/2020
• Initial Date FDA Received: 03/22/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1