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

Model Number 204

Device Problem Overfill (2404)

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

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

Event reported to bunnell (b)(6) 2023.Based on initial report, this event was determined to be not reportable as there was no patient injury reported.User facility report 3902560000-2023-8057 received 04/25/2023.This report is being submitted in response to the user facility report.The device has been received by bunnell.Investigation is currently in progress.A follow-up report will be submitted following completion of the investigation.

Event Description

As reported to bunnell on (b)(6) 2023: "flood water on the circuit, no injury to patient, will send in the circuit, (b)(6) wants jet looked at." as reported on user facility report 3902560000-2023-8057: "while patient was out of bed with mother, jet alarmed "high level" referring to the water level in the heater.Patient was removed from jet ventilator and provided ventilation with t-piece resuscitator.Jet ventilator was put through a system test without resolution of alarm.Jet was power cycled and put through a second system test without resolution.Original circuit removed and new circuit placed, alarm resolved.Prior to placing patient back on jet ventilator, entire circuit flooded with water.Jet was removed from service and tagged, patient was placed on new jet ventilator without complication.Patient remained stable for duration.No patient harm.".

Manufacturer Narrative

Event reported to bunnell 04/18/2025.Based on initial report, this event was determined to be not reportable as there was no patient injury reported.User facility report (b)(4) received 04/25/2023.Initial report submitted 05/25/2023 in response to the user facility report.Investigation has been completed.The reported symptom (flood water on the circuit, no injury to patient) could be verified and was reproduced exactly as reported.An internal inspection of the hfv found the right support bracket severely bent.The right support bracket (p/n: 03015-00) was replaced.The contact block (p/n: 03191-00), 2 receptacle solder cups (p/n: 00952-00), 7 receptacle solder cups (p/n: 00951-00), 7 probe contact spring (p/n: 00951), and 2 probe contact springs (p/n: 03307-00) were also replaced which restored normal operation.The hfv and pb were 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 was fully serviced and passed all applicable testing requirements.The damage observed was most likely due to mechanical impact due to droppage, crashing into a hard surface, etc.

Event Description

As reported to bunnell on 04/18/2023: "flood water on the circuit, no injury to patient, will send in the circuit, rt wants jet looked at." as reported on user facility report (b)(4): "while patient was out of bed with mother, jet alarmed "high level" referring to the water level in the heater.Patient was removed from jet ventilator and provided ventilation with t-piece resuscitator.Jet ventilator was put through a system test without resolution of alarm.Jet was power cycled and put through a second system test without resolution.Original circuit removed and new circuit placed, alarm resolved.Prior to placing patient back on jet ventilator, entire circuit flooded with water.Jet was removed from service and tagged, patient was placed on new jet ventilator without complication.Patient remained stable for duration.No patient harm.".

• Brand Name: BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR
• 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: 17010377
• MDR Text Key: 317074621
• Report Number: 1719232-2023-00001
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2019
• 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): Required Intervention