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

Model Number	F00007-1
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Per customer complaint, their monitron screen, used in conjunction with a ventilator, went blank while on a patient.No patient harm or injury reported.
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.Per customer statement, the monitron ii device, used in conjunction with the vdr ventilator device, screen went blank while in use on a patient.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 investigated internally, but the event could not be replicated.The system was confirmed to be working as intended.No patient harm or injury was reported.If any additonal information is received, a follow up mdr will be filed.

• Brand Name: MONITRON II
• Common Device Name: VDR WAVEFORM ANALYZER
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 130 mcghee road; suite 109; sandpoint ID
• 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: 18573530
• Report Number: 3029845-2024-00018
• Device Sequence Number: 20796447
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• 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: F00007-1
• Device Catalogue Number: S00015-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2018
• 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