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

Model Number SIPAP

Device Problems No Audible Alarm (1019); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The vyaire medical factory service received the suspect device, sipap ventilator, for evaluation.An evaluation of the device confirmed the reported issue and isolated the issue to a faulty alarm reed.

Event Description

The customer reported that the ventilator did not alarm when the gas was disconnected.There was no patient involvement associated with this issue.

Manufacturer Narrative

Results of investigation: the vyaire medical failure analysis laboratory received the suspect component, a blender bypass assembly alarm, and evaluated the component.An evaluation of the component verified the reported issue and isolated the issue to the reed flange was spaced too far away from the reed plate allowing excessive air to flow and causing the lack of alarm.

• 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: 7343750
• MDR Text Key: 102582362
• Report Number: 2021710-2018-07552
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

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: 675-CFG-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2007
• 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