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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BUNNELL, INCORPORATED LIFEPORT; VENTILATOR, HIGH FREQUENCY
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BUNNELL, INCORPORATED LIFEPORT; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 2.5 MM
Device Problem Break (1069)
Patient Problems Low Oxygen Saturation (2477); Diminished Pulse Pressure (2606)
Event Date 02/21/2021
Event Type  malfunction  
Event Description
Patient dropped both his heart rate and spo2, and was in need of ppv (positive pressure ventilation).Upon trying to remove the ventilator circuit from the ett, the injector attachment (green tube) of the lifeport adapter broke off causing a major loss of pressure in the circuit.The circuit then was stuck on the ett (endotracheal tube) adapter and had to be pried off with hemostats.The patient's vital signs were affected negatively by this equipment malfunction.This event actually occurred on [date redacted] @ 8:17 pm, clinical engineering received a work order# that day, for this lifeport adapter for bunnell jet, department did not mark it in the system as an incident.Clinical engineering sent this device to the manufacturer for evaluation and repair and the two patient boxes.
 
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Brand Name
LIFEPORT
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
BUNNELL, INCORPORATED
436 lawndale dr.
salt lake UT 84115
MDR Report Key12134419
MDR Text Key260475410
Report Number12134419
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 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2.5 MM
Device Catalogue Number9025
Device Lot Number20060786
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2021
Event Location Hospital
Date Report to Manufacturer07/08/2021
Type of Device Usage Unknown
Patient Sequence Number1
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