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

Model Number SIPAP

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: vyaire medical was able to verify the customer's reported issue during testing and evaluation.The reported issue was due to the cable assembly and led pcba.Vyaire medical replaced the cable assembly and led pcba to address the reported issue.

Event Description

It was reported to vyaire medical that the screen was white on the unit and the battery had been charged overnight.There was no patient involvement associated with this reported event.

Manufacturer Narrative

Results of investigation: the vyaire failure analysis lab received the suspected device/component and performed a failure investigation.The cable was not properly aligned causing a loss in electrical continuity.

• 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: 9100763
• MDR Text Key: 159519838
• Report Number: 2021710-2019-10816
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: SIPAP
• Device Catalogue Number: 27416-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1