MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. MONITRON; VDR WAVEFORM ANALYZER,

Model Number	F00007-1
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the monitron device is used with the vdr-4 ventilator, a life supporting device, and a malfunction was communicated to have occurred, this event is being reported.This mdr is being submitted delayed, as more information was trying to be obtained.At this time, no additional information has been received by the customer.Multiple attempts have been made to gather information related to the patient and event, but no response has been received.Additionally, the device has not been returned for internal investigation.If more information is received, a follow up mdr will be submitted.
Event or Problem Description
On (b)(6) 2025, it was communicated by the customer that the monitron device malfunctioned while in use on a patient.It was stated that the transducers were failing and providing inaccurate values on the display.No patient harm was reported.However, as the monitron device is used with the vdr-4 ventilator, a life-supporting device, this event is being reported.

• Brand Name: MONITRON
• Common Device Name: VDR WAVEFORM ANALYZER,
• 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: 23821414
• Report Number: 3029845-2025-00004
• Device Sequence Number: 9409894
• Product Code: CBK
• UDI-Device Identifier: 00849436000068
• UDI-Public: 00849436000068
• 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: 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: F00007-1
• Device Catalogue Number: S00015-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2020
• 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