MAUDE Adverse Event Report: BUNNELL, INC. LIFEPORT ADAPTER

Model Number 2.5 MM LPA

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2024

Event Type  Death  

Manufacturer Narrative

The user facility did not return the actual device to the manufacturer for investigation and evaluation.Retained samples for production lots shipped to the user facility were evaluated for structural integrity.Application of moderate lateral force to the lifeport body and connections had no effect.The lifeports reviewed were confirmed to meet all production requirements and specifications.Production records for these lots were reviewed with no indication of production issues.Complaint records were evaluated for potential similar events reported, with no similar events reported in the 2 years evaluated.Discussions with user facility staff suggest the event was unlikely a result of device failure, and rather the result of preexisting patient condition.The user facility indicated they evalauted other lifeports in their stock and concluded they were "pretty sturdy" and unlikely to have resulted in the event reported.The most likely cause of the lifeport damage described by the user facility is related to user error in patient management where the lifeport is stressed and cracked/broken through medical personnel action.However, the exact cause of this event could not be determined.

Event Description

User facility indicated they a had lifeport adapter (lpa) break on a patient where the lifepulse high frequency ventilator inserts the lpa.The user facility indicated the patient passed away.

• Brand Name: LIFEPORT ADAPTER
• Type of Device: LIFEPORT
• 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: 18975117
• MDR Text Key: 338532080
• Report Number: 1719232-2024-00002
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2.5 MM LPA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death