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

Model Number 203

Device Problems Decrease in Pressure (1490); Unexpected Shutdown (4019)

Patient Problem Hypoxia (1918)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

This event was initially reported in (b)(6) 2020.An investigation was completed and concluded that: "the reported symptom that the vent shut down could be verified.Operation in the hfv ready condition was very stable with minimum fluctuations, however due to dirty/fowled wafer terminals on the p1 connector of the valve drive regulator cca, a vent fault 10 and ventilator fault alarms could be made to be generated when the vdr caa was wiggled.The wafer terminals of the connector were cleaned with isopropyl alcohol which corrected the condition and restored normal operation.No problems were found with the hfv power supply and distribution systems and all distributed voltage were verified to be well within systems specifications.The system was verified to be in near perfect calibration condition and all control and monitoring circuitry was verified to responded correctly to all input variations.The hfv was thoroughly inspected and tested with no additional problems found.Hfv 2641 was fully serviced and passed all applicable testing requirements." given that all appropriate alarm systems and other safety measures were in place and functioning appropriately to prevent patient injury, it was determined, at that time, that this event was not reportable.This mdr is being filed in response to a request received from the fda for additional information related to user facility report (b)(4).

Event Description

As reported in user facility report (b)(4): "patient was desatting and the ventilator was on, but i didn't hear the scissor valve firing and noticed that the jet peak inspiratory pressure (pip) was set at 20 when it was supposed to be at 40.I then removed the baby from the ventilator and started neopuffing due to dropping sats.My coworkers and i tried to recalibrate the jet, and it stopped in the middle and turned off.We then tried again, and it stopped after 3 seconds.We then decided to pull in a new jet and switch ventilators.Unit was a bunnell rental jet ventilator, unit was returned to bunnell.No further action required.".

• Brand Name: BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR
• Type of Device: BUNNELL LIFEPULSE JET VENTILATOR
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city, ut
• Manufacturer (Section G): BUNNELL, INC.; 436 lawndale drive; salt lake city, ut
• Manufacturer Contact: curtis olsen ; 436 lawndale drive; salt lake city, ut ; 4670800
• MDR Report Key: 10374902
• MDR Text Key: 204232328
• Report Number: 1719232-2020-00002
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• 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