MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPULSE MODEL 203; LIFEPULSE HFJV

Model Number HFV 203

Device Problem High Readings (2459)

Patient Problem Respiratory Acidosis (2482)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer awareness date 08/05/2022.Date of report 09/02/2022.Device has not yet been returned to bunnell for evaluation.No investigation possible.User facility report 2100020000-2022-8004 received by bunnell on 08/19/2022.This report is being submitted in response to the user facility report.Initial review of user facility report and information provided by the facility suggests this event may have resulted from user error and incorrect setup of the device.A review of setup instructions indicates associated instructions provided to user facilities is accurate and sufficient to facilitate correct device setup.

Event Description

As reported to bunnell on (b)(6) 2022: high pip, low servo pressure, co2 was high while on patient, pinch value kinked.As reported on user facility report 2100020000-2022-8004: neonate with normal initial blood gas upon arrival to the nicu (neonatal intensive care unit), placed on jet vent for respiratory support.Subsequently, blood gas showed patient (pt) severely acidotic.Jet set to jpeep of 7, peep pressure reading noted to be 10, 12, & 15 over 12 hours.Pt developed pneumothorax.Chest tube inserted without improvement of acidosis.Later discovered that jet tubing was slightly misaligned from the pinch valve in the patient box.Once misalignment corrected, acidosis improved drastically.

Manufacturer Narrative

Manufacturer awareness date 08/05/2022.Date of report 09/02/2022.Initial event evaluation concluded this event was not reportable.User facility report (b)(4) received by bunnell on 08/19/2022.Initial report submitted in response to the user facility report prior to return of the device for evaluation.A review of setup instructions indicates associated instructions provided to user facilities is accurate and sufficient to facilitate correct device setup.The reported symptom (high peep, low servo pressure, co2 was high while on patient, pinch value kinked) could not be verified and was not reproduced as reported.The system was operated for over 7 days the pip always achieved the set point with minimal over and undershoot and the resultant servo pressure, map and peep always remained very stable and well within systems specifications with no negative display indications.The hfv and pb 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 2640 and pb 5803 was fully serviced and passed all applicable testing requirements user facility requested device be evaluated by ecri prior to return to bunnell.Conclusions from the ecri report include: "unlikely an electro-mechanical malfunction in the patient box contributed to the event" "during testing, in order for the bunnell ventilator to alarm, the tubing had to be almost completely dislodged from the pinch valve/patient box.Slight alignment was not enough to cause the ventilator to alarm." such misalignment would only occur due to user error during the setup process.Based on bunnell and ecri investigations, this event most likely resulted from user error during the setup process.No problem could be found with the device.

Event Description

As reported to bunnell on 08/05/2022: "high peep, low servo pressure, co2 was high while on patient, pinch value kinked." as reported on user facility report (b)(4): "neonate with normal initial blood gas upon arrival to the nicu (neonatal intensive care unit), placed on jet vent for respiratory support.Subsequently, blood gas showed patient (pt) severely acidotic.Jet set to jpeep of 7, peep pressure reading noted to be 10, 12, & 15 over 12 hours.Pt developed pneumothorax.Chest tube inserted without improvement of acidosis.Later discovered that jet tubing was slightly misaligned from the pinch valve in the patient box.Once misalignment corrected, acidosis improved drastically.".

• Brand Name: BUNNELL LIFEPULSE MODEL 203
• Type of Device: LIFEPULSE HFJV
• 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: 15462107
• MDR Text Key: 300358467
• Report Number: 1719232-2022-00002
• 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
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HFV 203
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2006
• 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