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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2020

Event Type  malfunction  

Event Description

Leaking high flow jet rental causing large puddle from the back of the unit.Jet replaced.Ventilator had a faulty cartridge which allowed for leaking of water.The ventilator was re-calibrated with new cartridge, circuit etc.And no issues were noted.The ventilator has since been returned to bunnell.Unfortunately, we do not have device identifiers.No harm to patient.

• Brand Name: BUNNELL JET VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; salt lake city UT 84115
• MDR Report Key: 10004774
• MDR Text Key: 189182776
• Report Number: 10004774
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1