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

Model Number SIPAP

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical reference number (b)(4).At this time, vyaire medical has not received the suspect device from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that during installation of the ventilator a burning smell was noted.There was no patient involvement associated with this issue.

Manufacturer Narrative

Results of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported issue could not be reproduced in the laboratory setting and no performance issues were found.

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7520166
• MDR Text Key: 108488056
• Report Number: 2021710-2018-07871
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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: 27475-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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