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

Device Problems Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

Bunnell jet alarming, (check circuit temp.) no temperature on panel noted.Circuit cold to touch.Troubleshooting done and then, jet switched out.Jet ventilator was pulled from patient bedside and replaced with additional vent.Bunnell was called and ventilator was returned to them.This bunnell jet vent was replaced with another vent and sent it to company for repair.Service report states no repair required - passed all testing specifications - operating correctly.

• Brand Name: BUNNELL JET VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL INCORPORATED; 436 lawndale dr.; salt lake UT 84115
• MDR Report Key: 12057349
• MDR Text Key: 258060396
• Report Number: 12057349
• 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: 06/15/2021

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: 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: 06/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA