MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW SIPAP; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number INFANT FLOW SIPAP

Device Problem Inaccurate Delivery (2339)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Vyaire medical has received the ventilator in question, however the evaluation has not yet begun.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that during set-up, the fio2 on the infant flow sipap ventilator was out of specification.Specifically, the customer advised the 21% and 100% were good but everything in between was off by 5%-7% according to the ventilator display.The customer advised there was no patient involvement associated with this event.

Manufacturer Narrative

Vyaire complaint #: (b)(4).Device evaluation: d10, g4, g7, h2, h3, h6, h10.Results of investigation: the vyaire failure analysis lab (fa lab) received the suspect component and performed a failure investigation.The reported problem was confirmed and duplicated.The unit failed the fio2 calibration.The unit was returned to the factory service dept.Where the blender was recalibrated and tested.The unit was returned to the customer and met factory service specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: INFANT FLOW SIPAP
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9927588
• MDR Text Key: 189670887
• Report Number: 2021710-2020-11762
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446004885
• UDI-Public: (01)10846446004885(11)20100219
• 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: 03/10/2020

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: SIPAP ENGL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1