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

Model Number 204

Device Problems Failure to Run on Battery (1466); Unexpected Shutdown (4019)

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

Event Date 06/04/2023

Event Type  malfunction  

Manufacturer Narrative

User facility notified bunnell of event on 06/05/2023.Investigation completed 06/22/2023.Given investigation results, it was determined this event was not reportable.User facility report (b)(4) received 06/22/2023.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 (battery issue, jet shut down) 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 and the battery was verified to be fully charged.The charging circuity of the vent was verified to be operating correctly.The initial battery runtime was found to be well within published minimum runtime specifications (runtime verified to be over 45 minutes).The systems calibration was optimized for peak performance and all control and monitoring circuitry was verified to be responding correctly to all input variations.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.Hfv fi subject unit was fully serviced and passed all applicable testing requirements.".

Event Description

As reported to bunnell on 06/05/2023: "battery issue, jet shut down." as reported on user facility report (b)(4): "called to patient room for malfunctioning jet vent alarms went off and vent lost pressure.Attempted to restart but it would not pressurize & all of the alarms on face of jet lit up & then the vent shut down.Replace with another jet.".

• 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: 17607995
• MDR Text Key: 321823324
• Report Number: 1719232-2023-00003
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 204
• 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