MAUDE Adverse Event Report: BUNNELL, INCORPORATED JET VENTILATOR; VENTILATOR, HIGH FREQUENCY

Device Problems Filling Problem (1233); Connection Problem (2900); Improper Flow or Infusion (2954); Temperature Problem (3022); Suction Failure (4039)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 05/07/2020

Event Type  malfunction  

Event Description

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 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: JET VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr.; salt lake UT 84115
• MDR Report Key: 12057751
• MDR Text Key: 258086296
• Report Number: 12057751
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA