MAUDE Adverse Event Report: BUNNELL, INC.; VENTILATOR, HIGH FREQENCY

Device Problems Increase in Pressure (1491); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  malfunction  

Event Description

High frequency jet ventilator (hfjv) malfunctioning while in use on a patient in the nicu.Servo pressures jumped from 2.4 to 10.Pip began fluctuating and an ventilator malfunction error displayed, alarm "pip not able to be met".Despite suctioning patient, repositioning patient, assuring all connections were properly attached, and assuring patient was intubated, the servo pressure continued to be extremely high.Discontinued ventilator and started a new hfjv.

• Type of Device: VENTILATOR, HIGH FREQENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 8599039
• MDR Text Key: 144690924
• Report Number: 8599039
• 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: 05/03/2019,04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Date Report to Manufacturer: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1