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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BUNNELL, INC. LIFEPULSE HIGH FREQUENCY JET VENTILATOR; VENTILATOR, HIGH FREQUENCY
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BUNNELL, INC. LIFEPULSE HIGH FREQUENCY JET VENTILATOR; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 204
Device Problems Failure to Cycle (1142); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2019
Event Type  malfunction  
Event Description
High frequency jet ventilator cycled off to standby mode and made a loud noise consistent with pressure relieving.Equipment was removed from patient and sent to biomed.Found that the jet ventilator on a patient was exceeding the pressure ordered and was releasing the pressure which caused the loud noise.The ventilator was removed from patient bedside and bio med was consulted.Equipment was checked out by bio-med.It was discovered the ventilator sensed a pressure above the ordered value and dumped the excessive pressure causing the noise associated with the what the respiratory therapist.Biomed sent rental unit back to bunnell to be serviced.
 
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Brand Name
LIFEPULSE HIGH FREQUENCY JET VENTILATOR
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
BUNNELL, INC.
436 lawndale dr.
s salt lake UT 84115
MDR Report Key8939232
MDR Text Key155810678
Report Number8939232
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 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number204
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/20/2019
Event Location Hospital
Date Report to Manufacturer08/28/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/28/2019
Type of Device Usage N
Patient Sequence Number1
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