MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW SIPAP; VENTILATOR, NON-CONTINUOUS

Model Number INFANT FLOW SIPAP

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.The device trained customer reported the suspect device/component will be re-worked.However, no device/component is available for analysis.In the event that the device/component is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported no audible alarm on this ventilator device during shut down.The customer stated no patient involvement with this event.

Manufacturer Narrative

Vyaire medical received the device and was able to duplicate the reported problem.The root cause was determined to be a bad main board.

• Brand Name: INFANT FLOW SIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9521855
• MDR Text Key: 189483077
• Report Number: 2021710-2019-11208
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446061925
• UDI-Public: (01)10846446061925
• Combination Product (y/n): N
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1