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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR; BUNNELL LIFE PULSE HFV
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BUNNELL, INC. BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR; BUNNELL LIFE PULSE HFV Back to Search Results
Model Number 203
Device Problems Overfill (2404); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Aspiration/Inhalation (1725)
Event Date 04/26/2017
Event Type  malfunction  
Manufacturer Narrative
The user facility has not returned this device to bunnell, inc.Pending completion of an internal investigation.
 
Event Description
The user reported that while the ventilator was running on a patient the humidifier began to alarm (temp high, circuit level low, circuit fault, continual audible alarm) and "888" was displayed in the humidifier temperature display.The respiratory therapist (rt) noticed a large amount of water in the circuit, which they hadn't noticed previously.The circuit was changed and ventilator was powered down with no resolution.The ventilator was replaced with another life pulse unit.Later that morning, the user facility reported that a significant amount of water had been delivered to the patient when this incident occurred.The patient's fio2 was increased from 21% to 50% following the incident.No other setting needed to be increased.The physician was concerned that the water delivered to the patient had washed out the previously administered surfactant and was considering giving another dose.
 
Manufacturer Narrative
He reported symptom that the humidifier alarmed with a constant audio alarm and all '8's in the temperature display could be verified and was reproduced exactly as reported.This 888 display indicates that the microprocessor controlling the humidifier was reset by the supervisory circuitry.When reset, the humidifier shuts off completely and alarms, disabling the heater, heater wire and water pump.Ventilator function is not affected.The supply voltage, monitored by the microprocessor supervisor, was found to be lower than that specified by bunnell to assure that the circuitry is not susceptible to electrical noise.To correct this issue, the five-volt supply regulator was replaced and all the contacts on the circuit board and in the power distribution cable cleaned.This restored normal operation and provided a degree of electrical noise isolation.Following the aforementioned service, the system was verified to be in calibration and all control and monitoring circuitry were verified to respond correctly to all input variations.The hfv was thoroughly inspected, tested and serviced with no other problems found.System's operation was very stable at a variety of pip and rate settings with no alarms in the hfv ready condition.Hfv 2835 was fully serviced and passed all applicable testing requirements.
 
Event Description
The user reported that while the ventilator was running on a patient the humidifier began to alarm (temp high, circuit level low, circuit fault, continual audible alarm) and "888" was displayed in the humidifier temperature display.The respiratory therapist (rt) noticed a large amount of water in the circuit, which they hadn't noticed previously.The circuit was changed and ventilator was powered down with no resolution.The ventilator was replaced with another life pulse unit.Later that morning, the user facility reported that a significant amount of water had been delivered to the patient when this incident occurred.The patient's fio2 was increased from 21% to 50% following the incident.No other setting needed to be increased.The physician was concerned that the water delivered to the patient had washed out the previously administered surfactant and was considering giving another dose.
 
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Brand Name
BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR
Type of Device
BUNNELL LIFE PULSE HFV
Manufacturer (Section D)
BUNNELL, INC.
436 lawndale drive
salt lake city UT 84115
Manufacturer (Section G)
BUNNELL, INC.
436 lawndale drive
salt lake city UT 84115
Manufacturer Contact
curtis olsen
436 lawndale drive
salt lake city, UT 84115
8014670800
MDR Report Key6603053
MDR Text Key76442242
Report Number1719232-2017-00001
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P850064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Respiratory Therapist
Remedial Action Repair
Type of Report Initial,Followup
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Respiratory Therapist
Device Model Number203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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