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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BUNNELL, INCORPORATED LIFEPULSE; VENTILATOR, HIGH FREQUENCY
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BUNNELL, INCORPORATED LIFEPULSE; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 203
Device Problems Failure to Calibrate (2440); High Test Results (2457)
Patient Problem Insufficient Information (4580)
Event Date 08/04/2022
Event Type  malfunction  
Event Description
Jet ventilator was checked and set-up appropriately, and about 2 hours later the jet vent values were reading high, which prompted the rt (respiratory therapist) to remove the patient off of the jet vent while another was manually ventilating with the ambu bag.The rt performed another calibration check which failed.The machine was pulled, and the patient was placed on the oscillator.The machine was tested again in the rt workroom, and it failed.When the patient box was exchanged, it passed the calibration test.The jet vent and patient box were brought to the 8th floor and sequestered for further evaluation.
 
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Brand Name
LIFEPULSE
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
BUNNELL, INCORPORATED
436 lawndale dr.
s salt lake UT 84115
MDR Report Key15257609
MDR Text Key298207654
Report Number15257609
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 Risk Manager
Type of Report Initial
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number203
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/15/2022
Event Location Hospital
Date Report to Manufacturer08/19/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age2 DA
Patient SexMale
Patient Weight4 KG
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