MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL WHISPER JET PATIENT BOX

Model Number 312

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 10/28/2017

Event Type  malfunction  

Manufacturer Narrative

An initial evaluation of the reported event did not indicate that this was a reportable adverse event.However, a copy of user facility report (b)(4) was received on 11/20/2017.This report is being submitted in response to the user facility report.The suspect device has not been returned to bunnell by the user facility.Therefore, no evaluation has been possible.A follow-up report will be submitted following completion of bunnell's investigation, which will take place after the unit is returned.Based on the reported symptom it appears that protective measures responded appropriately to prevent patient injury.

Event Description

Event description provided by the user facility to bunnell: vent had been running on baby and "shut off." user facility reported that a vent fault 02 appeared with the self test.This was with the same circuit that had been running on the baby.They reported that all connections looked fine including the purge tubing.No injury to patient resulted from the event.Event description from user facility medwatch (b)(4): 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.

Manufacturer Narrative

An initial evaluation of the reported event did not indicate that this was a reportable adverse event.However, a copy of user facility report (b)(4) was received on 11/20/2017.An initial report (dated 11/22/2017) was submitted in response to the user facility report.This follow-up report is being submitted to document the results of bunnell's investigation.The device was returned to bunnell for investigation on 12/14/2017.The reported symptom that the vent "shut off" with a vent fault 02 alarm could not be verified and was not reproduced as reported.The system operated in a very stable manner with minimum fluctuations of all monitored values and no alarm conditions of any type.The patient box and high frequency ventilator were verified to be operating correctly.Multiple performances of the self test never resulted in the generation of a vent fault 02 or any other system alarm.Operation on all patient box axes at a variety of settings for over 19 days resulted in very stable operation, well within applicable control specifications.All systems control, monitoring and processing circuitry was verified to be operating correctly and responding accurately.Both the ventilator and patient box were found to be in near perfect calibration condition.The hfv and pb were thoroughly inspected, tested and serviced with no problems found that could cause or be responsible for the reported symptoms.Systems operation was very stable at a variety of controls pip and rate settings with no alarms in the hfv ready condition.High frequency ventilator (b)(4) and patient box (b)(4) were fully serviced and passed all applicable testing requirements.

Event Description

Event description provided by the user facility to bunnell: vent had been running on baby and "shut off." user facility reported that a vent fault 02 appeared with the self test.This was with the same circuit that had been running on the baby.They reported that all connections looked fine including the purge tubing.No injury to patient resulted from the event.Event description from user facility medwatch (b)(4): 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 WHISPER JET PATIENT BOX
• Type of Device: BUNNELL WHISPER JET PATIENT BOX
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• MDR Report Key: 7060517
• MDR Text Key: 93598943
• Report Number: 1719232-2017-00003
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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
• Device Operator: Respiratory Therapist
• Device Model Number: 312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 10/28/2017
• Supplement Dates FDA Received: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention