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

Model Number 203

Device Problems Overheating of Device (1437); Overfill (2404)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Event Description

The heater water chamber on the jet alarmed that chamber was too full and would not stop.Called (b)(6) and spoke with representative.He advised respiratory therapist (rt) to empty some water from the chamber by removing the green tubing from the gas outlet, lifting the water cartridge out of its holder and empty some of the water from the chamber back through the green tubing.This worked for a while, but then the jet started alarming that the water chamber was too hot.At this point it appeared that there was very little water in the chamber.Rt called (b)(6) again and spoke with the same representative, who advised that he change out the jet, which we did.Then, the jet appeared to run without difficulty.No harm to the patient.

• Brand Name: LIFE PULSE
• Type of Device: VENTILATOR, HIGH FREQUENCY, CIRCUIT
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 8662375
• MDR Text Key: 146794568
• Report Number: 8662375
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/21/2019,05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2019
• Date Report to Manufacturer: 06/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1