MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR; LIFEPULSE HIGH FREQUENCY JET VENTILATOR, OR JET

Model Number 203

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event occurred on (b)(6) 2019.At the time of the initial report it was determined that the information provided did not indicate that the event was reportable.The device was not returned to bunnell until 08/07/2019.Following a detailed investigation it was determined that the event would be reported.The investigation was completed and results approved on 08/22/2019.The date of this report is 08/23/2019.The reported symptom of a negative peep display indication could not be verified and was not reproduced as reported.Operation was very stable with minimum fluctuations and with no negative peep indication observed.The pip, peep and servo pressure always remained very stable and well within systems specifications.The reported symptom that the pump was not working could be verified and was reproduced exactly as reported.A failure of the mid-level signal spring contact probe on the 9-pin contact block of the humidifier cartridge assembly caused a false cartridge full signal to be processed which in turn prevented the pump from operating.The replacement of the spring contact probe restored normal operation.The system was found to be in near perfect calibration condition and all monitoring, processing and control circuitry was verified to be operating correctly and responding accurately.The hfv was thoroughly inspected, tested and serviced with no other problems found.Systems operation was very stable at a variety of controls pip and rate settings with no alarms in the hfv ready condition.Hfv 8078 was fully serviced and passed all applicable testing requirements.A review of the failed component indicated that the contact pin had been bent such that proper electrical contact could not be achieved.This type of damage and failure is most likely to occur as a result of incorrect system set up with the associated disposable being aggressively installed in an incorrect location.The likelihood that this failure mode would occur under normal use conditions, if the proper set up (as described in the user manual) is followed, is negligible.The damaged component is housed behind a latching door.Additionally, the disposable that interacts with the spring contract probe has guide pins which ensure proper installation.In order for the pin to become damaged both of these safety mechanisms must be subverted, most likely due to user error.It is noted that the user facility that experienced this issue is a teaching facility that does not treat patients.Therefore, this event had no patient involvement.

Event Description

As reported to bunnell by the user facility: "humidifier pump not pumping, peep reading negative even after changing out patient box.".

• Brand Name: BUNNELL LIFEPULSE HIGH FREQUENCY VENTILATOR
• Type of Device: LIFEPULSE HIGH FREQUENCY JET VENTILATOR, OR JET
• 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: 8932556
• MDR Text Key: 191197176
• Report Number: 1719232-2019-00005
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2013
• 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