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

Model Number 203

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2023

Event Type  malfunction  

Event Description

Upon assessing infant, ett (endotracheal tube) appeared intact, but the ventilator had a "ventilator fault" message appear on the machine.Infant received ppv (positive pressure ventilation) for approximately 8mins while vent machine was being calibrated by rt (respiratory therapist).Rt stated that jet passed calibration, but he had to switch to a different wall plug.

• Brand Name: LIFEPULSE JET VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 17189789
• MDR Text Key: 317745269
• Report Number: 17189789
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2023,06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 203
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24 DA
• Patient Sex: Female