MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. SINUSOIDAL BRONCHOTRON; VENTILATOR

Model Number	F00038-2
Medical Device Problem Codes	Infusion or Flow Problem (2964); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, the respiratory therapist accompanying the patient while in transport, indicated that the device started chugging/hesitating and then stopped working completely.The patient had to be manually ventilated.
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.Due to the customer stating the malfunction occurred during required patient ventilation, this incident is deemed reportable.Due to this failure, the end user had to manually ventilate the patient for an extensive period.The system was returned and evaluated by percussionaire and it was determined that a failed cartridge triggered the failure in pressure output.The cartridge was replaced and the device returned to functioning correctly.The cartridge was investigated independently for determination of root cause and it was concluded that the presence of external debris caused the component to fail.Currently, there have been no similar incidents reported.Any similar incidents' will be evaluated and escalated accordingly.No additional information has been received on the patient.Any additional information on this incident will be submitted as a follow-up mdr.

• Brand Name: SINUSOIDAL BRONCHOTRON
• Common Device Name: VENTILATOR
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 18571872
• Report Number: 3029845-2024-00005
• Device Sequence Number: 8203409
• Product Code: CBK
• UDI-Device Identifier: 00849436000235
• UDI-Public: 00849436000235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K905235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 01/24/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown