MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR; BUNNELL LIFE PULSE HFV

Model Number 203

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

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

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

The reported symptom that the ventilator stopped venting could be verified and was reproduced exactly as reported.An intermittent servo pressure transducer would cause a false servo pressure display of 19.6 psi which would cause the system to generate random loss of pip, cannot meet pip and vent fault 10 alarms which would cause the vent to stop venting.The servo pressure transducer was replaced which restored system stability.The complete systems calibration was performed with no drift over time observed.The hfv was thoroughly inspected, tested and fully calibrated with no other problems found.The system stabilized at the default controls settings with all monitored values remaining very stable with very little fluctuations.(b)(4) was fully serviced and passed all applicable testing requirements.The ventilator fault 10 alarm condition reported is a risk control measure in place to prevent aberrant system behavior when an electrical abnormality is detected.This risk control measure functioned as designed, and intended, by shutting down the system when such electrical conditions were detected.There is no indication that the ventilator fault 10 condition was inappropriately initiated.Bunnell completed a failure investigation pertaining to this reported event on 05/05/2016, with a resolution letter send to the user facility on 05/06/2016 summarizing the results of the investigation.At the time of the investigation it was determined that this event, as reported by the user facility, was not reportable under part 803; therefore, no form 3500a was submitted at that point.On 05/24/2016 bunnell received a copy of user facility report (b)(4).This report is being submitted in response to the user facility report.The risk control measures (device protective systems) within the ventilator system functioned as designed, and no patient injury was reported.

Event Description

Event description from user facility form 3500a ((b)(4)): "earlier this year, a bunnell instruments ventilator stopped working while in use.No patient harm was reported as a respiratory therapist was able to manually support the patient.The unit stopped venting after being operating normally for a couple of days.A sudden ventilator fault alarm went off, causing the unit to go into standby and dashes were displayed on the display panel.Rt at bedside turned the ventilator off and back on, ran through self test which ventilator passed.Unit was replaced by another ventilator to be able to properly conduct an incident investigation."unit was check with manufacturer and were able to reproduced the same problem.It was found that an intermittent servo pressure transducer would cause a false servo pressure display of 19.6 psi which would cause the system to generate random loss of pip, cannot meet pip and vent fault 10 alarms which could cause the vent to stop venting."the servo pressure transducer was replaced which restored system stability and a complete system calibration was performed with no drift over time observed." event description, as provided by the user facility when bunnell was first notified of the event/complaint on 04/19/2016: "stopped venting".Additional information received 04/20/2016: patient had been ventilated on life pulse hfv for 4 days without incident.Sudden ventilator fault alarm, jet went into standby, and dashes were displayed on the display panel.The respiratory therapist at the bedside turned the ventilator off and back on, and ran it through self-test, which the ventilator passed.The ventilator was running with a ups in place.Patient was placed back on the ventilator for 4-5 hours.Alarm did not recur; however, the ventilator was switched out for a different jet so that further investigation could be completed.When the ventilator was running in the lab, it passed self-test and operational tests and ran with normal operations for an extended period of time.

• Brand Name: BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR
• Type of Device: BUNNELL LIFE PULSE HFV
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer (Section G): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• Manufacturer Contact: curtis olsen ; 436 lawndale drive; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 5729990
• MDR Text Key: 47550755
• Report Number: 1719232-2016-00003
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2016

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: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other