MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPULSE; LIFEPULSE HFV

Model Number 203

Device Problem Calibration Problem (2890)

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

As reported to bunnell on 06/13/2023: "check vent fault appeared when nurse was with patient.Called for an rt and when the rt arrived the fault alarm was gone.Rt left patient on jet and there was no incident after that, but the director wanted to remove the jet for safety reasons and have it replaced.Biomed called the vent in after running for some time with no issues.Still want vent checked out." as reported on user facility report (b)(4): "upon assessing infant, ett (endotracheal tube) appeared intact, but the ventilator had a "ventilator fault" message appear on the machine.Infant received ppv (positive pressure ventilation) for approximately 8mins while vent machine was being calibrated by rt (respiratory therapist).Rt stated that jet passed calibration, but he had to switch to a different wall plug.".

Manufacturer Narrative

User faciltiy notified bunnell of event on 06/13/2023.Investigation completed 07/17/2023.Given investigation results, it was determined this event was not reportable.User facility report (b)(4) received 06/23/2023.Review of this report did not affect reportability determination.This event is not reportable.Fda request for additional information received 07/25/2023.This report submitted in response to this request.Investigation of this event concluded that the reported symptom (check vent fault appeared when nurse was with patient.Called for an rt and when the rt arrived the fault alarm was gone.Rt left patient on jet and there was no incident after that, but the director wanted to remove the jet for safety reasons and have it replaced.Biomed called the vent in after running for some time with no issues.Still want vent checked out.) could not be verified and was not reproduced.However within approximately 3 hours of operation the humidifier reset.The input voltage to the max691cpe microprocessor supervisor of the humidifier processor cca was found to be at +4.8193 vdc which is below our allowable tolerances.The wafer terminals (p/n: 00890-00) pin 1 of p1 on the power supply cca and pin 5 of p2 on the humidifier processor cca were replaced which increased the voltage on the max691cpe microprocessor supervisor of the humidifier processor cca to +4.9379 vdc.The hfv was thoroughly inspected, tested and operationally verified to have no additional problems.The system stabilized at the default controls settings with all monitored values remaining very stable with very little fluctuations.The hfv fi subject unit and the pb fi subject unit were fully serviced and passed all applicable testing requirements.

• Brand Name: BUNNELL LIFEPULSE
• Type of Device: LIFEPULSE 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: 17608002
• MDR Text Key: 321823459
• Report Number: 1719232-2023-00004
• 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: 08/21/2023

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 Model Number: 203
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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