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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/02/2019

Event Type  malfunction  

Event Description

The jet ventilator failed on nicu patient.The peep reading was 14 instead of 5.The servo peep was set at 2 and jet reading at 14.The nnp was informed and at bedside.The patient was bagged and switched to the servo while new jet set up.The jet was in standby.Before jet taken off arterial blood gas values (abg) widely out of range and blood pressure low.After jet off, abg back to normal.The equipment was sent to (b)(4).

• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale dr.; salt lake city UT 84115
• MDR Report Key: 8554509
• MDR Text Key: 143233708
• Report Number: 8554509
• Device Sequence Number: 0
• 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: 04/16/2019,03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/16/2019
• Date Report to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2019
• Type of Device Usage: N
• Patient Sequence Number: 1