MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR; LIFEPULSE JET VENTILATOR

Model Number 204

Device Problems Display or Visual Feedback Problem (1184); Insufficient Heating (1287)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to bunnell, and an investigation completed in (b)(6) 2020.The reported symptom of not reading the temperature and a humidifier check circuit alarm could not be verified and was not reproduced as reported.Operation was very stable in the hfv ready condition with no alarms of any type generated.The cartridge heater plate and circuit heater wire were verified to be operating correctly and the humidifier monitored temperatures were stable and accurate.No problems of any type were found with the humidifier processor cca.There is nothing wrong with this device.The systems calibration was optimized for peak performance and all control and monitoring circuitry was verified to be responding correctly to all input variations.Hfv a1307 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 such, no manufacturer report was filed at that time.However, user facility report (b)(4) was received on (b)(6) 2021.Although this event is not reportable, this report is being submitted in response to this user faciltiy report within 30 days of its receipt.

Event Description

As reported on user facility report (b)(4): "bunnell jet alarming, (check circuit temp.) no temperature on panel noted.Circuit cold to touch.Troubleshooting done and then, jet switche out.Jet ventilator was pulled from patient bedside and replaced with additional vent".As reported to bunnell at the time of the event: "no temp reading, alarm check circuit temp." no patient injury.

• Brand Name: BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR
• Type of Device: LIFEPULSE JET VENTILATOR
• 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: 12258823
• MDR Text Key: 264492939
• Report Number: 1719232-2021-00003
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1