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

Model Number	S00015-1
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per customer complaint received on (b)(6) 2026, the monitron display, which is used with the vdr-4 ventilator, experienced a white screen on the third day of patient use.The customer restarted the device a few times, however, the issue would not resolve itself.The multimeter on the vdr device was also not displaying any data.
Additional Manufacturer Narrative
This event is being reported as there was a malfunction to a life-supporting device, the monitron ii used in conjunction with the vdr-4 ventilator.No patient harm was reported by the customer.It was communicated that medical intervention was required due the monitron screen presenting as white, as well as the vdr-4 multimeter display showing no readings.Both devices were returned for internal investigation.The monitron white screen could not be replicated.The internal batteries were tested and determined to be low, in which they were replaced.When assessed, the vdr-4 multimeter was confirmed to not be working.It was concluded that the batteries also required replacing, which was completed.All other functional evalution tests for both products were completed and found to be passing.At this time, no additional information is available.If additional information is presented, a follow up mdr will be submitted.

• 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: 24021250
• Report Number: 3029845-2026-00001
• Device Sequence Number: 8952315
• Product Code: CBK
• UDI-Device Identifier: 00849436000068
• UDI-Public: 00849436000068
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/09/2026

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: 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: 12/10/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2008
• 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