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

Model Number	F0007-1
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.Per customer statement, the monitor ii device, used in conjunction with the vdr ventilator device, screen froze while in use.As there was a malfunction to the vdr/monitor ii device that may lead to uncertainty of ventilation and as a result, may interrupt the ventilation support, this mdr is being filed.The device was received back and evaluated.Through investigational testing, it was determined that the root cause of the issue was due to the transducer board failure.The transducer board was replaced and the device was confirmed to be working appropriately.The device was sent back to the customer after this repair.No additional information has been received on this incident or the patient.If any additional information is received, a follow up mdr will be filed.
Event or Problem Description
Per customer complaint, while device was in use on a patient, the monitor screen froze.No patient intervention was required, other than suctioning.The monitor resumed functioning and unfroze after the respiratory therapist pressed display mode and scale buttons.No patient injury or harm reported.

• Brand Name: MONITRON II
• Common Device Name: VDR WAVEFORM ANALYZER
• 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: 18573350
• Report Number: 3029845-2024-00012
• Device Sequence Number: 9080709
• Product Code: CBK
• UDI-Device Identifier: 00849436000068
• UDI-Public: 00849436000068
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• 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: F0007-1
• Device Catalogue 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: 10/21/2022
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2018
• 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