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

Model Number 203

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

This event was initially reported to bunnell on 07/10/2019.The device was received on 07/15/2019 and an investigation was completed.The reported symptom that the jet stopped working on a patient could be verified and was reproduced as a vent fault 06 during operation.A failure of a nand gate component on the hfv processor cca prevented an enable signal from being applied to a demultiplexer component which interrupted the normal operation of the digital processing circuitry, resulting in the generation of a vent fault 06.The replacement of the nand gate component restored normal systems operation.The system was verified to be in near perfect calibration condition and all control and monitoring circuitry was verified to respond correctly to all input variations.The hfv was thoroughly inspected, tested and serviced with no other problems found.Systems operation was very stable at a variety of controls pip and rate settings with no alarms in the hfv ready condition.Hfv 8203 was fully serviced and passed all applicable testing requirements.At the time of the investigation it was determined that this event was not reportable as there was no reported injury to the patient and appropriate alarms and mitigations are in place, and were functioning, to prevent patient injury.However, user facility report (b)(4) was received on 10/07/2019.This report is being submitted in response to this user facility report.

Event Description

As reported to bunnell on 07/10/2019: "stopped working on patient, no injury." as reported on user facility report (b)(4): "bunnell jet alarm going off respiratory therapist (rt) went over to check found jet stopped and reset to default settings, infant desaturating to low 80's.There was no noted glitch or flicker in electricity.Checked circuit to make sure all connections were secure, tight and nothing was kinked.Reset appropriate settings and restarted jet.This happened 2x's more and error code 05 was seen on jet screen, and then rt proceeded to switch out jet.Error code 05 is an electrical irregularity has disrupted the microprocessor, corrective action was to power off life pule for 3-4 mins and then power back on.Rt opted to change out device." the user facility's report to bunnell indicated that there was no injury to the patient.Additionally, user facility report (b)(4) indicates that there was no negative outcome or adverse event attributed to the event.

• Brand Name: BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR
• Type of Device: LIFE PULSE HIGH FREQUENCY JET VENTILATOR, OR JET
• 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: 9205706
• MDR Text Key: 216679668
• Report Number: 1719232-2019-00008
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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