Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BUNNELL, INCORPORATED BUNNELL JET VENTILATOR; VENTILATOR, HIGH FREQUENCY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BUNNELL, INCORPORATED BUNNELL JET VENTILATOR; VENTILATOR, HIGH FREQUENCY Back to Search Results
Device Problems Calibration Problem (2890); Pressure Problem (3012); Intermittent Loss of Power (4016)
Patient Problem Low Oxygen Saturation (2477)
Event Date 01/21/2020
Event Type  malfunction  
Event Description
Patient was desatting and the ventilator was on, but i didn't hear the scissor valve firing and noticed that the jet peak inspiratory pressure (pip) was set at 20 when it was supposed to be at 40.I then removed the baby from the ventilator and started neopuffing due to dropping sats.My coworkers and i tried to recalibrate the jet, and it stopped in the middle and turned off.We then tried again, and it stopped after 3 seconds.We then decided to pull in a new jet and switch ventilators.Unit was a bunnell rental jet ventilator, unit was returned to bunnell.No further action required.Equipment was removed from patient, while patient was supported by staff.Ventilator was returned to bunnell.Bunnell communicated via email two days later that they are conducting a failure investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BUNNELL JET VENTILATOR
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
BUNNELL, INCORPORATED
436 lawndale dr.
salt lake city UT 84115
MDR Report Key10004775
MDR Text Key189184839
Report Number10004775
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2020
Event Location Hospital
Date Report to Manufacturer04/28/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/28/2020
Type of Device Usage N
Patient Sequence Number1
-
-