MAUDE Adverse Event Report: VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems Failure to Cycle (1142); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

Field service rep evaluation: the field service engineer (fse) went on-site to evaluate the suspect device.The fse performed the operational verification procedure for the device and the device met manufacture specifications.The reported event was not duplicated and no assembly failure was identified.However, the device was due for a hardware preventative maintenance change, which was performed by the fse.

Event Description

The customer reported the ventilator device stopped cycling, while in patient use.The customer stated no known patient harm or injury was reported.The customer reported using a different patient circuit and the device seemed to cycle fine.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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: avery foster ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7609918
• MDR Text Key: 111339915
• Report Number: 2021710-2018-07983
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/18/2018

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: 3100A
• Device Catalogue Number: PS-768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2002
• 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