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

Model Number UNKNOWN

Device Problems Failure to Power Up (1476); Complete Loss of Power (4015)

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

Event Date 05/10/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility did not notify bunnell of this event.The associated device was not returned to bunnell for investigation.Therefore, no investigation was possible.Based on a review of complaint and service records, no complaint or service activity corresponding to this event could be located.This report is being submitted in response to user facility report (b)(4) which was received by bunnell on 07/01/2021 with a stated event date of 05/10/2020.

Event Description

As described in user facility report (b)(4): "bunnell jet shut down and could not be restarted.Ventilator was placed on patient and then shut down during use.Ventilator was unable to be restarted.Vent.Removed from patient and work order placed.No harm to patient.Power breaker in the back of vent was off.".

• Brand Name: BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR
• Type of Device: BUNNELL LIFEPULSE JET VENTILATOR
• 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: 12258824
• MDR Text Key: 264498783
• Report Number: 1719232-2021-00004
• 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: Other
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1