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

Model Number 203

Device Problems No Audible Alarm (1019); No Display/Image (1183); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2016

Event Type  malfunction  

Manufacturer Narrative

When the complaint was first received on 07/11/2016 it was determined that this event was not reportable; however, as additional information was received the event was reevaluated for reportability.The hfv was thoroughly inspected, tested and functionally verified to have no problems.The hfv powered-up and initialized normally.The self test was performed numerous times with no alarm conditions of any type generated.The ventilator was verified to be operating correctly and to specifications.No display problems or anomalous operation was observed.The system never had any trouble achieving the hfv ready condition and no alarms of any type were generated in either the non-ready or ready condition.The hfv power supply and distribution systems were thoroughly tested with no problems found.Operational input voltage tolerance testing indicates a robust device which is very tolerant to input voltage variations.Long term systems operation over a wide range of pip and rate settings resulted in very stable operation with no alarms of any type being generated.To further verify the operational integrity, the hfv was operated for an additional 68 hours under environmental conditions which raised the internal device temperature above that of a normally operating device, with no problems of any type observed and with no alarms generated.All alarm conditions relevant to the airway pressure signal (loss of pip, cannot meet pip, high pip) and system alarms (vent fault 03, vent fault 10 and the digital vent vault alarms) were verified to be actively responding when triggered and the system power off alarm was verified to be operating correctly.No gas leaks or any other type of problems were found with the pneumatics assembly and the pwm control and feedback circuitry was verified to be operating and responding correctly.Nothing could be found with this device which could cause or be responsible for the reported symptoms.

Event Description

The ventilator display panel electronically "went out", with the settings and readings blank.The humidifier temperature display was not affected.The ventilator stopped working and was no longer ventilating the patient.The user facility reported that no alarm was generated when the ventilator function stopped.The patient was manually ventilated and stabilized.The life pulse unit was taken off the patient for testing.After the ventilator was reset by cycling the power off then back on, the numbers and display came back up but the jet did not go into systems test when the test button was pressed.A ventilator fault alarm was generated when the user facility attempted additional testing the next day.

• 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: 5901227
• MDR Text Key: 52945153
• Report Number: 1719232-2016-00005
• 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: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Respiratory Therapist
• Device Model Number: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2008
• 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