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 Display/Image (1183); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical complaint number (b)(4).The vyaire medical factory service center received the suspect device, sipap ventilator, for evaluation.An evaluation of the device duplicated the reported issue and found a bad cable switch and the a/c power connecter was damaged.The evaluation isolated the reported issue to a bad connection.The factory service center repaired the device and the device meets manufacturer's specifications.

Event Description

The customer reported that prior to starting a preventative maintenance procedure on the ventilator, the display kept going out and coming back.The customer performed a preventative maintenance procedure.After the preventative maintenance, the ventilator alarmed error code e21 and the display went blank during the performance verification.There was no patient involvement associated with this 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: 7345627
• MDR Text Key: 102644909
• Report Number: 2021710-2018-07565
• 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: 03/16/2018

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: 675-CFG-005-RFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• 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