MAUDE Adverse Event Report: BUNNELL INCORPORATED LIFE PULSE HIGH FREQUENCY VENTILATOR; JET VENTILATOR

Model Number 203A

Device Problems Device Displays Incorrect Message (2591); Moisture or Humidity Problem (2986)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 03/25/2015

Event Type  Injury  

Event Description

Jet ventilator alarmed "high temp" and excess fluid was noted in the circuit.The fluid went through the circuit tubing and down the pt's et tube.The pt's airway was suctioned and the fluid was removed.The pt desaturated and became bradycardic.Chest compressions were required and the pt was placed on a different jet ventilator.

• Brand Name: LIFE PULSE HIGH FREQUENCY VENTILATOR
• Type of Device: JET VENTILATOR
• Manufacturer (Section D): BUNNELL INCORPORATED; 436 lawndale dr., south; salt lake city UT 94115
• MDR Report Key: 4691955
• MDR Text Key: 5640883
• Report Number: 4691955
• Device Sequence Number: 1
• Product Code: LSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 203A
• 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: 03/27/2015
• Distributor Facility Aware Date: 03/25/2015
• Device Age: 5 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 10 YR
• Patient Weight: 1