MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR; BUNNELL LIFE PULSE HFV

Model Number 203

Device Problem Overfill (2404)

Patient Problem Aspiration/Inhalation (1725)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

The reported symptom that the humidifier stopped working with all alarms and displays lit up was unable to be reproduced.The system operated in a very stable manner without incident for almost 6 days with no interruptions in operation or uncommanded shut downs observed.The cartridge was repeatedly drained and always filled to the correct level with no alarms generated and never overfilled as was reported.Repeated draining and filling of the patient breathing circuit cartridge always resulted in the water level achieving the mid-level sense pin at which point the pump stopped operation.The water level never exceeded the mid-level sense pin and no humidifier level low or level high alarms or a cartridge overfill condition occurred during long term testing.The hfv was thoroughly inspected and tested with no problems found.

Event Description

It was reported that while on the patient, the humidifier alarmed with all red words illuminated at the same time, water overfilled the circuit and was delivered to the patient, temperature read out of 88.8.Patient was then maintained on conventional ventilation and switched to hfov.The user facility reported that they had to often press the wait button twice in a row to get the humidifier to fill.

• Brand Name: BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR
• Type of Device: BUNNELL LIFE PULSE HFV
• 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: 5901223
• MDR Text Key: 52945833
• Report Number: 1719232-2016-00006
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other