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

Model Number UNKNOWN

Device Problem Overfill (2404)

Patient Problems Bradycardia (1751); Hypoxia (1918)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Bunnell has no record indicating the user facility was unable to resolve this issue following any potential call to bunnell's technical and/or clinical support teams.The user facility did not notify bunnell of any inability to troubleshoot and resolve this event.The associated device was not returned to bunnell for investigation.Therefore, no investigation was possible.Based on a review of complaint and service records, no complaint or service activity corresponding to this event could be located.This report is being submitted in response to user facility report (b)(4) which was received by bunnell on 07/01/2021 with a stated event date of (b)(6) 2020.

Event Description

As indicated on user facility report (b)(4): "noticed heater on jet ventilator off and circuit cold to the touch, heater turned on, high level alarm noted, troubleshooting performed (cartridge reseated, connections checked), water cycled into humidifier, overfilling cartridge, high level alarm went off, water entered circuit and lavaged patient, patient hr and spo2 dropped, attempted to suction but suction was not connected, md at bedside, patient removed from vent, md started manual resuscitation, hr and spo2 quickly increased, ett (endotracheal tube) suctioned, water removed from circuit prior to placing patient back on ventilator.Ventilator was alarming high-water level in the humidifier of the jet bunnell.Troubleshooting guide was referenced without result.Manager at bedside called technical support at bunnell.Instruction was given to turn the humidifier off for 15-20 minutes and allow the water level to evaporate as the ventilator was running and then turn the humidifier back on after the appropriate time.Technical support communicated that this should resolve the issue, as occasionally the tubing pulls too much water into the cartridge upon initiation of the ventilator, to no fault of the operator.He instructed that the only other option was to remove the patient from the ventilator and manually ventilate them while extracting approximately 5 ml of water from the cartridge, if the patient was stable enough to tolerate being removed from the ventilator.It was determined that the patient was not stable enough to tolerate being removed from the ventilator.It was determined that the patient was not stable enough to tolerate as ventilator settings were high, patient was maxed on ino, with saturations in the 50's.Parents were at the bedside and visibly distressed.Therapist was instructed to turn the ventilator humidifier back on after 20 minutes, if the humidifier continued the issue to repeat the process until such a time that the patient could be removed, and secondary process performed".

• 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 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: 12258882
• MDR Text Key: 264497551
• Report Number: 1719232-2021-00005
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1