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

Device Problem No Pressure (2994)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2023

Event Type  malfunction  

Event Description

Called to patient room for malfunctioning jet vent alarms went off and vent lost pressure.Attempted to restart but it would not pressurize & all of the alarms on face of jet lit up & then the vent shut down.Replace with another jet.

• Brand Name: BUNNELL JET VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INCORPORATED; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 17181115
• MDR Text Key: 317666971
• Report Number: 17181115
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/14/2023

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male