MAUDE Adverse Event Report: BUNNELL, INCORPORATED BUNELL HIGH FREQUENCY JET VENTILATOR; VENTILATOR, HIGH FREQUENCY

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  malfunction  

Event Description

High frequency ventilator circuit leaking water, circuit found to have a crack at humidifier inlet.Circuit changed out while infant was neopuff ventilated.The circuit of the jet ventilator was found to be cracked at one of the inlet ports.The baby was neopuffed and the circuit was changed out.Filed a report with bunnell company about the jet circuit.The circuit was sent back to bunnell and a new circuit was sent for a replacement.

• Brand Name: BUNELL HIGH FREQUENCY JET VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr.; salt late city UT 84115
• MDR Report Key: 8961687
• MDR Text Key: 156494507
• Report Number: 8961687
• 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: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1