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

Model Number 3100A

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Results of investigation: a vyaire medical field service representative (fsr) evaluated the device onsite.The fsr removed dust from the inside of the ventilator and installed a replacement 7 year driver power module.The fsr installed new gas filters and a new 9v battery.The fsr performed the 7 year preventative maintenance procedure.The device meets manufacturer's specifications.The vyaire medical failure analysis laboratory received the suspect component, a 3100a driver power module, for evaluation.Upon completion of the device evaluation, a follow-up report will be submitted.

Event Description

The customer reported that the ventilator stopped oscillating, while in use on a patient.The ventilator was removed and re-placed on the patient and the ventilator stopped again.There was no patient harm associated with this issue.The customer was not able to duplicate this issue after the ventilator was removed from the patient.

Manufacturer Narrative

Results of investigation: the vyaire medical failure analysis laboratory received the suspect component, a 3100a driver power module, and evaluated the component.An evaluation of the component did not duplicate the reported issue.The component meets manufacturer's specifications.

• 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: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7088123
• MDR Text Key: 93888463
• Report Number: 2021710-2017-07091
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/1997
• 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