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

Model Number SIPAP

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: the vyaire medical factory service center received the suspect device, a sipap ventilator.An evaluation of the component confirmed the reported issue and isolated the issue to the alarm printed circuit board (pcb).Factory service replaced the alarm pcb and the unit meets manufacturer's specifications.

Event Description

The customer reported that the power off alarm did not sound when the unit was turned off.There was no patient involvement associated with this issue.

Manufacturer Narrative

The vyaire medical failure analysis laboratory received the suspect component, a sipap main printed circuit board assembly (pcba), and evaluated the device.An evaluation of the component duplicated the reported issue and isolated the issue to a super capacitor on the main pcba not holding charge.

• 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: 6836600
• MDR Text Key: 84353369
• Report Number: 2021710-2017-06540
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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: 27444-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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