MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. VDR-4; VENTILATOR

Model Number	F00008-1
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the patient requiring unintended medical intervention, in which the device was exchanged for another to prevent the patient from further declining, and that the device in this event is a life-supporting device, this event is being reported.The device was returned for internal investigation on december 1, 2025.The vdr-4 underwent procedural functional evaluation and demonstrated to be working properly.The event could not be replicated as the customer communicated.As the event could not be reproduced, there are no actions at this time.If additional information is received or a trend is observed with similar issues, a follow-up mdr will be submitted.
Event or Problem Description
On (b)(6) 2025, it was reported that while a vdr-4 device was in use on a patient, the customer representative had difficulty adjusting the controls on the vdr-4 ventilator.It was communicated that the device controls were unresponsive and the ventilator continuously alarmed.The ventilator had to be exchanged to avoid any further patient decline.Due to the unintended medical intervention, this report is being submitted.

• Brand Name: VDR-4
• Common Device Name: VENTILATOR
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 03864
• Manufacturer (Section G): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID 03864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 23821413
• Report Number: 3029845-2025-00003
• Device Sequence Number: 13114109
• Product Code: CBK
• UDI-Device Identifier: 00849436000044
• UDI-Public: 00849436000044
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: F00008-1
• Device Catalogue Number: S00018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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