MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL INC. LIFEPULSE 203; VENTILATOR, HIGH FREQUENCY

Device Problem Leak/Splash (1354)

Patient Problems Aspiration/Inhalation (1725); Death (1802)

Event Date 03/20/2020

Event Type  malfunction  

Event Description

Water from the humidifier cartridge flowed into the pt's circuit and et tube causing the pt to aspirate the water.Patient died.Address questions to: (b)(6) or to: (b)(6).Fda safety report id# (b)(4).

• Brand Name: BUNNELL INC. LIFEPULSE 203
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC. ; salt lake city UT 84115
• MDR Report Key: 10185016
• MDR Text Key: 196134225
• Report Number: MW5095155
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 DA