MAUDE Adverse Event Report: BUNNELL, INCORPORATED LIFEPORT ADAPTER; VENTILATOR, HIGH FREQUENCY

Model Number 2.5 MM

Device Problems Increase in Pressure (1491); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2023

Event Type  Injury  

Event Description

Patient was placed on high frequency jet ventilator and immediately experienced high servo pressures.On further inspection of the circuit and ventilator, it was found to have a small tear in the lifeport adapter.

• Brand Name: LIFEPORT ADAPTER
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr.; salt lake city UT 84115
• MDR Report Key: 16852508
• MDR Text Key: 314366180
• Report Number: 16852508
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2023,04/26/2023

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?: Yes
• Device Operator: Other
• Device Model Number: 2.5 MM
• Device Catalogue Number: 9025
• Device Lot Number: 22112801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female