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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2020

Event Type  malfunction  

Event Description

Bunnell jet shut down and could not be restarted.Ventilator was placed on patient and then shut down during use.Ventilator was unable to be restarted.Vent.Removed from patient and work order placed.No harm to patient.Power breaker in the back of vent was off.This bunnell jet is a rental, does not belong to our facility and is not maintained by clinical engineering.No further action required by clinical engineering.

• Brand Name: BUNNELL JET
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr.; salt lake UT 84115
• MDR Report Key: 12057753
• MDR Text Key: 258085857
• Report Number: 12057753
• 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
• 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