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

Model Number	F00007-1
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being re-evaluated in february 2024 as part of newly implemented procedures.As there was a malfunction to the vdr/monitron ii device that may lead to uncertainty of ventilation and as a result, may interrupt the ventilation support, this mdr is being filed.At the time of the event, the monitron device was manufactured by a third-party manufacturer.The device was sent to the manufacturer and it was concluded to be an issue with the processor software version, version 1.7, and electronic chip combination.The device was reverted back to the previous processor software revision, version 1.6, as well as the electronic chip was changed to an approved alternative chip.This combination corrected the screen freeze issue.As this was a systemic issue, a fsca was reported to fda retrospectively in october 2023 under 1000524541-10/02/2023-001-c.No additional information has been received for this specific incident.If any additional information is received, a follow up mdr will be filed.
Event or Problem Description
Per complaint received by the customer, while in use on a patient in conjunction with a ventilator, the monitron display was freezing consistently.The customer stated to reset the device by turning it off and then back on.However, the device still resulted in a screen freeze.The monitron and ventilator was swapped for another device and the issue was stated to be resolved.No patient injury or harm was reported.

• Brand Name: MONITRON II
• Common Device Name: VDR WAVEFORM ANALYZER
• Manufacturer (Section D): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 18806891
• Report Number: 3029845-2024-00034
• Device Sequence Number: 7295103
• Product Code: CBK
• UDI-Device Identifier: 00849436000068
• UDI-Public: 00849436000068
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Notification
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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: 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): Periodic
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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