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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BUNNELL, INC. LIFE PULSE HIGH FREQUENCY VENTILATOR; VENTILATOR, HIGH FREQUENCY
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BUNNELL, INC. LIFE PULSE HIGH FREQUENCY VENTILATOR; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 203A
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Respiratory Failure (2484)
Event Date 01/26/2018
Event Type  malfunction  
Event Description
The rate on the high frequency jet ventilator was increased by the therapist from (b)(4) and immediately the high fluid level alarm activated.The therapist immediately recognized the water was in the circuit and that it had reached the patient.She quickly disconnected the jet ventilator and provided manual ventilation through a bag valve mask device connected to the nitric oxide at (b)(4) parts per (b)(4).The infant was not placed back on the jet or any device per the families wishes.Manufacturer response for ventilator, life pulse high frequency (per site reporter).Manufacturer would like to review vent and circuit.
 
Manufacturer Narrative
The following elements have blank data.
 
Event Description
The rate on the high frequency jet ventilator was increased by the therapist from 360 to 420 and immediately the high fluid level alarm activated.The therapist immediately recognized the water was in the circuit and that it had reached the patient.She quickly disconnected the jet ventilator and provided manual ventilation through a bag valve mask device connected to the nitric oxide at 20 parts per million.The infant was not placed back on the jet or any device per the families wishes.Manufacturer response for ventilator, life pulse high frequency (per site reporter).Manufacturer would like to review vent and circuit.
 
Event Description
The rate on the high frequency jet ventilator was increased by the therapist from 360 to 420 and immediately the high fluid level alarm activated.The therapist immediately recognized the water was in the circuit and that it had reached the patient.She quickly disconnected the jet ventilator and provided manual ventilation through a bag valve mask device connected to the nitric oxide at 20 parts per million.The infant was not placed back on the jet or any device per the families wishes.Manufacturer response for ventilator, life pulse high frequency (per site reporter).Manufacturer would like to review vent and circuit.
 
Manufacturer Narrative
The following elements have blank data.
 
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Brand Name
LIFE PULSE HIGH FREQUENCY VENTILATOR
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
BUNNELL, INC.
436 lawndale drive
salt lake city UT 84115
MDR Report Key7247108
MDR Text Key99218051
Report Number7247108
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number203A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2018
Event Location Hospital
Date Report to Manufacturer02/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT APPLICABLE.
Patient Weight1
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