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

Lot Number 18109242

Device Problems Fracture (1260); Defective Component (2292)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event was initially reported to bunnell on (b)(6) 2019.The device was received on 02/06/2019 and an investigation was completed.The reported symptom of "broken circuit at the green tubing port" was confirmed.A visual inspection of the returned patient breathing circuit indicated that the port with the green "gas-in" tube was broken away from the pbc cartridge body.Due to the physical damage of the pbc, electrical response characteristics testing, operational verification, and long-term stability testing were not performed.At the time of the investigation it was determined that this event was not reportable as there was no reported injury to the patient and appropriate alarms and mitigation's are in place, and were functioning, to prevent patient injury.However, user facility report (b)(4) was received on 09/15/2019.This report is being submitted in response to this user facility report.

Event Description

As reported to bunnell on (b)(6) 2019: "broken circuit at the green tubing port." as reported on user facility report (b)(4): "high frequency ventilator circuit leaking water, circuit found to have crack at humidifier inlet.Circuit changed out while infant was neopuff ventilated.The circuit of the jet ventilator was found to be cracked at one of the inlet ports.The baby was neopuffed and the circuit was changed out.Filed a report with bunnell company about the jet circuit.The circuit was sent back to bunnell and a new circuit was sent for a replacement." the user facility's report to bunnell indicated that there was no injury to the patient.Additionally, user facility report (b)(4) indicates that there was no negative outcome or adverse event attributed to the event.

• Brand Name: BUNNELL PATIENT CIRCUIT
• Type of Device: PATIENT BREATHING CIRCUIT
• 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: 9205704
• MDR Text Key: 194453466
• Report Number: 1719232-2019-00007
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 18109242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2019
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1