MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPULSE; LIFEPULSE HIGH FREQUENCY VENTILATOR

Model Number 203

Device Problems Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The reported symptom of a humidifier ram failure alarm could not be verified and was not reproduced as reported.The humidifier was verified to be operating correctly with no alarms of any type generated.Both the circuit and cartridge heater drive and temperature monitoring circuitry of the humidifier processor cca.Were found to be operating correctly and the displayed temperatures were verified to be accurate and stable.Although no problems could be found, as a precaution the humidifier processor cca.Was replaced.The system was verified to meet all calibration requirements.The hfv was thoroughly inspected, tested and operationally verified to have no problems.Hfv 8202 was fully serviced and passed all applicable testing requirements.It is bunnell's assessment that this event is not reportable; however, this report is being submitted in response to user facility report (b)(4).

Event Description

As reported by the user facility to bunnell on (b)(6) 2021: "continuous tone, humidifier unresponsive, 111 in humidifier display." not related to patient injury.As reported on user facility report (b)(4): "bedside renal therapist (rt) called the rt educator to the bedside to assess a situation with jet#2 ventilator.The vent had a continuous beeping sound and the heater was not working.The jet temperature window displayed 11.1 and 22.2.Rt was unable to silence or reset the alarm.During this high beeping sound, the vent worked well with all vent settings displayed correctly, and the patient still had chest wiggle.As a result of this, there was no harm done to the patient.Rt called the bunnell hotline support service.When described what was happing, the bunnell personnel suspected a problem with the internal hardware malfunction and could not be fixed while on patient-advised to switch out the vent and take it to biomed.The vent was successfully switched out as instructed, and the patient remained stable on the new vent.".

• Brand Name: BUNNELL LIFEPULSE
• Type of Device: LIFEPULSE HIGH FREQUENCY VENTILATOR
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city UT 84115
• MDR Report Key: 11343814
• MDR Text Key: 280451771
• Report Number: 1719232-2021-00001
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1