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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

Rental bunnell hf (high frequency) jet malfunctioned.Baby given ppv (positive pressure ventilation) while bunnell hfjet was switched out.No harm to patient.

• Brand Name: LIFE PULSE HIGH FREQUENCY JET VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawnale dr.; salt lake city UT 84115
• MDR Report Key: 14928944
• MDR Text Key: 295323885
• Report Number: 14928944
• 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: 06/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1