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

Model Number 00212

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed in response to a request received from the fda for additional information related to user facility report (b)(4).This event was not previously reported to bunnell.Additional information was not available from the user facility.User facility did not return the disposable in question to bunnell for investigation.No investigation was possible.As reported by the user facility, there was no impact to the patient due to this event.

Event Description

As reported in user facility report (b)(4): "leaking high flow jet rental causing large puddle from the back of the unit.Jet replaced.Ventilator had a faulty cartridge which allowed for leaking of water.The ventilator was re-calibrated with new cartridge, circuit etc.And no issues were noted.The ventilator has since been returned to bunnell.Unfortunately, we do not have device identifiers.No harm to patient.".

• Brand Name: BUNNELL PATIENT CIRCUIT
• Type of Device: BUNNELL PATIENT BREATHING CIRCUIT (PBC)
• 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: 10374860
• MDR Text Key: 240359848
• Report Number: 1719232-2020-00003
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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