MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPORT ADAPTER; ENDOTRACHEAL TUBE JET ADAPTER

Catalog Number 9025

Device Problem Decrease in Pressure (1490)

Patient Problems Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility did not notify bunnell of this event.Although user facility report 1000060000-2021-8064 indicates that the device was returned to the manufacturer, the associated device was not returned to bunnell for investigation (no return authorization was requested by the user facility in relation to this event, and no unexpected device was received).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 1000060000-2021-8064 which was received by bunnell on (b)(6) 2021 with a stated event date of (b)(6) 2021.

Event Description

As indicated on user facility report 1000060000-2021-8064: "patient dropped both his heart rate and spo2, and was in need of ppv (positive pressure ventilation).Upon trying to remove the ventilator circuit from the ett, the injector attachment (green tube) of the lifeport adapter broke off causing major loss of pressure in the circuit.The circuit then was stuck on the ett (endotracheal tube) adapter and had to be pried off with hemostats.The patient's vital signs were affected negatively by this equipment malfunction.Clinical engineering received a work order# that day, for this lifeport adapter for bunnell jet, department did not mark it in the system as an incident.Clinical engineering sent this device to the manufacturer for evaluation and repair and the two patient boxes.".

• Brand Name: BUNNELL LIFEPORT ADAPTER
• Type of Device: ENDOTRACHEAL TUBE JET ADAPTER
• 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: 12258850
• MDR Text Key: 264522861
• Report Number: 1719232-2021-00006
• 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 Catalogue Number: 9025
• Device Lot Number: 20060786 (UNABLE TO CONFIRM)
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1