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

Model Number INFANT FLOW SIPA

Device Problem No Pressure (2994)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).At this time, vyaire has not received the suspect device/component for evaluation.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 that the sipap ventilator could not build peep.The customer advised there was no patient involvement associated with this event.

• Brand Name: INFANT FLOW SIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8727570116
• MDR Report Key: 9634700
• MDR Text Key: 187718817
• Report Number: 2021710-2020-11325
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446063592
• UDI-Public: (01)10846446063592(11)20150904
• Combination Product (y/n): N
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFANT FLOW SIPA
• Device Catalogue Number: 27476-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1