MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL PATIENT CIRCUIT; HFV PATIENT BREATHING CIRCUIT

Model Number 00212

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Aspiration/Inhalation (1725)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

The reported symptom that pbc 20010396 delivered large amounts of water to the patient could not be verified and was not reproduced as reported.Long term operational testing for over 7 days never resulted in excessive humidification or rain out being generated within the circuit gas out tubing and no alarms of any type were generated.The monitored temperatures remained very stable and accurate.The monitored pip, peep, servo pressure and map all remained very stable with minimum fluctuations throughout the testing period.The level sense pins were verified to be operating and responding correctly and the cartridge consistently filled to the correct level.The initial electrical response characteristics were verified to be well within systems specifications and there were no operational or characteristic degradation of the patient breathing circuit relative to the initial analysis following long term operational verification testing.There is nothing wrong with this patient breathing circuit from lot number 20010396.It should be noted that, per the user facility's report to bunnell, there was no patient injury associated with this event.However, as there is a potential for injury if the event reoccurred, and out of an abundance of caution, this event is being submitted as a 30-day report.

Event Description

User facility reported that they experienced "a jet circuit malfunction that was new on a patient and was noted to be delivering large amounts of water to the 22 weaker it was on.".

• Brand Name: BUNNELL PATIENT CIRCUIT
• Type of Device: HFV PATIENT BREATHING CIRCUIT
• Manufacturer (Section D): BUNNELL, INC.; 436 lawndale drive; salt lake city, ut
• Manufacturer (Section G): BUNNELL, INC.; 436 lawndale drive; salt lake city, ut
• Manufacturer Contact: curtis olsen ; 436 lawndale drive; salt lake city, ut ; 4670800
• MDR Report Key: 10123112
• MDR Text Key: 195614486
• Report Number: 1719232-2020-00001
• 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: Other
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00212
• Device Catalogue Number: 938
• Device Lot Number: 20010396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention