MAUDE Adverse Event Report: PERCUSSIONAIRE BROCHONTRON; VENTILATOR

Model Number	F00038-2
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the end user that on january 2, 2020, the care team arrived to the patient's location and noticed the patient was in a state of extremis.When attempting to use the ventilator, it failed prior to use on the patient.It was stated the device was unable to register pressure on the device multimeter and a loud leak was heard.The patient had to be manually ventilated during transport to the hospital.A second incident occurred on (b)(6) 2020, in which again the same ventilator device failed prior to use on a patient in the same manner.
Additional Manufacturer Narrative
This event is being re-evaluated in 2024 due to newly implemented procedures.As the patient required the medical intervention of manual ventilaiton due to product failure, this event is deemed reportable.The device was evaluated by percussionaire and the root cause was determined to be a failure of an internal harness tied to a check valve assembly had failed.The harness with the check valve assembly was replaced and confirmed to be working appropriatley.No further information was received on patient status.If any additional information is obtained, a follow up mdr will be filed.

• Brand Name: BROCHONTRON
• Common Device Name: VENTILATOR
• Manufacturer (Section D): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 18699241
• Report Number: 3029845-2024-00032
• Device Sequence Number: 7352454
• Product Code: CBK
• UDI-Device Identifier: 00849436000235
• UDI-Public: 00849436000235
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K905234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F00038-2
• Device Catalogue Number: S00033-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown