MAUDE Adverse Event Report: BUNNELL INCORPORATED BUNNELL; VENTILATOR, HIGH FREQUENCY

Model Number	312
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Nicu patient was on the jet ventilator when the ventilator displayed ventilator fault and shut down.The ventilator was turned off and then back on with nothing working still.Patient was manually ventilated while a new vent was brought over.It was a lengthy process, so the patient was manually ventilated for about 20 minutes.The patient was placed on the new jet ventilator and was stable.Bunnell was contacted and we are troubleshooting the problem with the ventilator.

• Brand Name: BUNNELL
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL INCORPORATED; 436 lawndale drive; salt lake city UT 84115
• MDR Report Key: 7040463
• Report Number: 7040463
• Device Sequence Number: 16563285
• Product Code: LSZ
• UDI-Device Identifier: 00616120000013
• UDI-Public: (01)00616120000013
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2017
• Report Date (Section F): 10/30/2017

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
• Operator of Device: No Information
• Device Model Number: 312
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/30/2017