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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
Device Problems False Alarm (1013); Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  malfunction  
Event Description
Bedside renal therapist (rt) called the rt educator to the bedside to assess a situation with jet#2 ventilator.The vent had a continuous beeping sound and the heater was not working.The jet temperature window displayed 11.1 and 22.2.Rt was unable to silence or reset the alarm.During this high beeping sound, the vent worked well with all vent settings displayed correctly, and the patient still had chest wiggle.As a result of this, there was no harm done to the patient.Rt called the bunnell hotline support service.When described what was happing, the bunnell personnel suspected a problem with the internal hardware malfunction and could not be fixed while on the patientadvised to switch out the vent and take it to biomed.The vent was successfully switched out as instructed, and the patient remained stable on the new vent.
 
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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 Key11284973
MDR Text Key230466234
Report Number11284973
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 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2021
Event Location Hospital
Date Report to Manufacturer02/05/2021
Type of Device Usage Unknown
Patient Sequence Number1
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