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	05/29/2020
Type of Reportable Event	Malfunction
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.The device would only reset if turned off and turned back on.No patient harm or injury was reported.
Additional Manufacturer Narrative
This incident is being re-evaluated in (b)(6) 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.The system was sent back to percussionaire for evalution.The event itself could not be re-created.At the time of this event in 2020, the monitron device was manufactured by an outsourced manufacturer.The monitron was sent to said manufacturer, in which they replaced a module on the motherboard and it was confirmed to correct the issue.No additional information was received on this incident.No patient harm or injury was reported.If any additional information is received, a follow up mdr will be filed.

• 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: 18606439
• Report Number: 3029845-2024-00030
• Device Sequence Number: 9033891
• 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: 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2020
• 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