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

Device Problem Pressure Problem (3012)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

Servo pressure on jet ventilator decreased significantly on two separate occasions, causing the patient to brady and desat.Company called and suggested to replace patient box.Box was replaced.After the investigation, it was noted the pressures decreased on the jet ventilator which the respiratory therapist (rt) noticed.The patient was taken off the vent and neo puffed.The rt called the support line for the (b)(6) company.Through the discussion, it was determined to change the patient box out.This was completed and the pressures on the jet came back into the ordered parameters.The defective patient box is being sent back to the (b)(6) company.No harm was caused to the patient from this event.

• Brand Name: LIFEPULSE
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; s salt lake UT 84115
• MDR Report Key: 9980817
• MDR Text Key: 188345118
• Report Number: 9980817
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2020
• Date Report to Manufacturer: 04/21/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 365 DA