MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFE PULSE HIGH FREQUENCY VENTILATOR; BUNNELL LIFE PULSE HFV

Model Number 203

Device Problems Device Inoperable (1663); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Death (1802)

Event Date 05/11/2016

Event Type  Death  

Manufacturer Narrative

The reported symptom of a vent fault 06 alarm could not be verified or reproduced during normal operation; however, when the input voltage was reduced 8vac lower than the minimum systems operational input voltage specification of 105 vac a vent fault 06 was generated.Nevertheless, this indicates this device exhibits excellent tolerance to input voltage variations.The system operated without incident for over 5 days with all monitored values remaining very stable with minimum fluctuations and interruptions or uncommanded shut downs observed.The power supply and distribution system were thoroughly tested and verified to be well within specifications, but as a precaution relative to the reported symptom, the vr1 voltage regulator and the b1 bridge rectifier were replaced and all pins and sockets of the +5vdc distribution system were cleaned with isopropyl alcohol to further improve the reliability of the +5 vdc supply.The system was verified to be in near perfect calibration condition and all control and monitoring circuitry was verified to respond correctly to all input variations.The hfv was thoroughly inspected, serviced and tested with no problems found.Systems operation was very stable at a variety of controls pip and rate settings with no alarms in the hfv ready condition.(b)(4) was fully serviced and passed all applicable testing requirements.The ventilator fault 06 alarm condition is a risk control measure in place to prevent aberrant system behavior when an electrical abnormality is detected.This risk control measure operated as designed, and intended, by shutting down the system when such electrical conditions were detected.There is no indication that the ventilator fault 06 condition was inappropriately initiated.This hospital had sent a biomed tech to bunnell's service training program in 2013.No service records were forwarded to bunnell.Our last service report was dated 11/29/2012.The lifepulse hfv operator's manual "warnings and precautions" section states that "precaution: in accordance with good medical practices, when operating critical equipment, it is recommended to have back-up equipment available." additionally, the "troubleshooting" section states that in response to a ventilator fault 06 alarm (as reported), the user should "turn power to life pulse off to reset it and then turn power back on.If life pulse passes the self-test, and operational test, restart on patient and call the bunnell hotline." in relation to this type of alarm, the operator's manual repeatedly stresses that the user should "call the bunnell hotline to determine if the life pulse needs to be replaced." as per the user's report to bunnell, this device experienced a vent fault 06 alarm on another patient earlier on the day that this event occurred.However, the facility did not contact the bunnell hotline at that time, as indicated in the manual.Although the unit passed subsequent self testing, the operator's manual clearly indicates that the user facility should have determined if the unit needed to be removed from service through troubleshooting and/or by calling the bunnell hotline.The user provided no indication that any troubleshooting was performed to determine the cause of the alarm condition before this unit was placed into service on another patient.Furthermore, bunnell was not contacted about the adverse event, which occurred on (b)(6) 2016, until a week after the patient expired (bunnell notified of event on (b)(6) 2016).No device failure was identified.The system was only found to malfunction when operated outside of specifications (input voltage well below the minimum systems operational voltage).The system was not in use on the patient at the time of the adverse event (patient death).Additionally, the patient was, as reported, suffering from "bad" persistent pulmonary hypertension of the newborn at the time the life pulse was initiated on the patient.Therefore, it has been determined that a life pulse device failure did not directly result in the adverse event.However, combined with potential user error (due to failure to follow the instructions in the operator's manual and failure to troubleshoot the cause of an alarm condition prior to use of the device on another patient), the reported issue was related to a disruption in therapy condition which may have contributed to the adverse event.

Event Description

The respiratory therapist that was there at the time was (b)(6).He said that the patient had bad pphn (persistent pulmonary hypertension of the newborn) and they had tried other ventilators but could not stabilize the patient.The patient was switched to the life pulse early in the am on (b)(6) 2016.The patient had started to improve on the life pulse when a vent fault 06 alarm was generated which caused the life pulse to shutdown with an alarm.The patient was manually ventilated while they tried to restart the life pulse by cycling the main power and pressing enter.The life pulse went back into the vent fault 06 alarm shutdown.They did not have a backup life pulse so one was ordered.They attempted to stabilize the patient by switching to hfov, but this therapy was not adequate and the patient expired.(b)(6) reported that this same vent had experienced a vent fault 06 on another patient earlier that day but they were able to restart it at that time.

• 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 Key: 5721124
• MDR Text Key: 47265084
• Report Number: 1719232-2016-00002
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/1991
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death