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

Model Number SIPAP

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

Results of investigation: vyaire medical has not received the suspect device at this time.Once received and evaluated, a follow-up medwatch report will be submitted.

Event Description

It was reported to vyaire medical that while in use on a patient, the unit failed.There was no harm to the patient, the patient was immediately removed.At the time of the event, the unit alarmed "e33".

• Brand Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8203609
• MDR Text Key: 131647718
• Report Number: 2021710-2018-09732
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIPAP
• Device Catalogue Number: 27428-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2018
• 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
• Patient Outcome(s): Required Intervention