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); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, the customer has not responded to requests for additional information regarding this event.  in the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that the end-user noticed a burning smell and then the oscillator overheat led lit up and the driver stopped, while the ventilator was in use on a patient.The user let the device cool down and tried to run it again for testing, without a patient, but the ventilator shut down again.After two hours of testing, the user removed the patient circuit diaphragm and found that the driver had ruptured.At this time, it is unknown if there was any patient harm/injury associated with this issue.

Event Description

There was no patient harm/injury associated with the reported issue.

Event Description

The customer reported that when the device stopped suddenly, the respiratory therapist used an artificial manual breathing unit (ambu) bag to ventilate the patient.The patient was placed onto a conventional ventilator.A blood gas test was performed on the mechanical ventilator and the results were acceptable.

• 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: 7317198
• MDR Text Key: 101619800
• Report Number: 2021710-2018-07492
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P890057
• 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,Followup
• Report Date: 04/04/2018

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: 768909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/06/2018; 03/06/2018
• Supplement Dates FDA Received: 03/06/2018; 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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
• Patient Outcome(s): Required Intervention