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

Model Number 203

Device Problems Display or Visual Feedback Problem (1184); Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The reported symptom of excessive map could not be verified and was not reproduced as reported.Operation was very stable with no alarms of any type generated and no problems of any type were found with the hfv display.The pip always achieved the set point with minimum fluctuations and the servo pressure, map and peep were always very stable and well within systems specifications with the peep verified to be responsive.No problems were found with the hfv power system, pneumatic system or with the hfv processor and driver ccas.All control and feedback signals were verified to be operating correctly and responding accurately.The system was verified to be well within calibration specifications.The hfv was thoroughly inspected, tested and operationally verified to have no problems of any type.Hfv 8152 was fully serviced and passed all applicable testing requirements.Date of incident was (b)(6) 2020.At that time the user facility only notified bunnell of a potential display issue.Based on the information initially provided this event was determined to not be reportable.However, at the time the unit was returned to bunnell the user facility notified bunnell that the patient had passed away; however, they did not specifically link the patient's passing to any potential malfunction of this device.Bunnell's aware date of the patient's condition was (b)(4) 2020.This report was completed within 30 days of this awareness date.

Event Description

Patient was placed on standby on the jet for a procedure, when placed back on the jet, the map read consistently 14.5 or above, even if the peep was turned down to 5 or less.User facility performed the following troubleshooting: changed out lifeport adapter.Changed out patient box.Performed a power on self test - passed just fine.Performed an operational test.The peep would read zero but the map never read less than 14.5 or more.Discontinued use of the device as to not be changing settings incorrectly.A bunnell hotline call was received at the time; however, the call did not involve the condition of a patient, settings being utilized on the patient, or for advice on making any adjustments for the patient.Rather, the call involved potential issues with the monitoring section of the lifepulse ventilator.It was reported the jet had been placed into standby while the care team tended to a procedure with the patient.It was reported at conclusion of the procedure the patient was placed back on the lifepulse and enter was used to restart the device.It was reported it was at this time they noticed the monitored numbers and called the hotline.At no time was information about the patient pathophysiology, situation, condition, or care plan provided to bunnell.Bunnell was not made aware of the patient's condition until the unit was being returned for investigation.

• Brand Name: BUNNELL LIFEPULSE
• Type of Device: LIFEPULSE HIGH FREQUENCY 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: 11628163
• MDR Text Key: 246975357
• Report Number: 1719232-2021-00002
• 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
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 203
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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