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

Model Number 203

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

Received call from (b)(6) (rt) saying that "jet had shut down and failed on a patient".They switched out the jet for a different unit to support the patient.They tested the "failed" jet an it resulted in a vent fault 03 a few times before he called.He did say, patient decompensated after the jet shut off (decompensation and desaturation to 70).Patient recovered and was stabilized and transitioned to another jet.No injury to the patient.

Manufacturer Narrative

The reported symptom giving a vent fault 03 error code could be verified and was reproduced exactly as reported.Additionally a jet valve fault, ventilator fault and a loss of pip alarm were generated almost immediately during the operational verification testing.A microcircuit component on the hfv processor cca (or gate u30), which controls the operation of the pwm valves, purge valve, solenoid and dump valve, had failed.The microcircuit was replaced and the hfv was thoroughly inspected, tested, and functionally verified to have no other problems.No additional discrepancies were found.This was the first confirmed failure of this component in the history of the hfv device.

• Brand Name: BUNNELL
• Type of Device: LIFE PULSE HFV
• Manufacturer (Section D): BUNNELL, INC.; salt lake city UT
• Manufacturer Contact: curtis olsen ; 436 lawndale dr.; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 4177394
• MDR Text Key: 5163045
• Report Number: 1719232-2014-00005
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 203
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• 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
• Patient Outcome(s): Required Intervention