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

Model Number 312

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2017

Event Type  malfunction  

Event 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
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL INCORPORATED; 436 lawndale drive; salt lake city UT 84115
• MDR Report Key: 7040463
• MDR Text Key: 92354427
• Report Number: 7040463
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 00616120000013
• UDI-Public: (01)00616120000013
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 312
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1