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

Model Number SIPAP

Device Problems Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical complaint number (b)(4).Results of investigation: the vyaire medical factory service center received the suspect device, a sipap ventilator, and evaluated the device.An evaluation of the device confirmed the reported issue and isolated the issue to the blender being out of calibration.

Event Description

The customer reported that the blender in the sipap ventilator was not working correctly.When the blender was set to (b)(4) or (b)(4), it seemed to work fine.If the blender was set to anywhere between (b)(4) and (b)(4), the blender seemed to be (b)(4) off.If the blender knob was set to (b)(4), it would only deliver (b)(4).If the blender was set to (b)(4), it would only deliver (b)(4).There was no patient involvement associated with this reported issue.

• 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: 6841116
• MDR Text Key: 84629359
• Report Number: 2021710-2017-06569
• 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: Health Professional
• Type of Report: Initial
• Report Date: 09/04/2017

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: SIPAP ENGL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• 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