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	05/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is being reported as there was a malfunction to a life-supporting device, the monitron ii, which used in conjunction with the vdr-4 ventilator.The monitron was communicated to experience a blank screen while in use on a patient.However, no patient harm was reported by the customer and the ventilator was stated to continue to function as intended.The device was not returned for evaluation, and therefore, a root cause could not be determined.If additional information is obtained, a follow up mdr will be submitted.
Event or Problem Description
Monitron screen went blank while in use on a patient.The monitron is used in combination with a vdr ventilator.The ventilator still functioned as intended and there was no impact to the patient.No harm was reported by the customer.

• 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: 25548764
• Report Number: 3029845-2026-00002
• Device Sequence Number: 16137606
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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): Initial
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown