MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. 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	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being re-evaluated in january 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.It was determined the screen freeze was due to a electronics problem as well as faulty software.The correction made to the device was the replacement of the pal chip, as well as reverting back to the previous software version.These components were corrected and confirmed to be working appropriately within the systems.At this time, no additional information has been received on this incident or patient.Originally, no patient harm or injury was reported.A follow up mdr will be submitted if additional information is received.
Event or Problem Description
Per customer complaint received by percussionaire distributor, while in use in conjunction with a ventilator on a patient at the time of the incident, the monitron screen was stated to be freezing every 4-5 hours and not displaying accurate information.The respiratory therapists had to rely on the manometer.The monitron/vdr were swapped out for a functioning system.No patient harm or injury stated by customer.

• 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: 18606254
• Report Number: 3029845-2024-00029
• Device Sequence Number: 15722824
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2015
• 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