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

Model Number	F00007-1
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.As there was a failure to the monitron display, which was used in conjunction with the vdr ventilator on a patient at the time of failure, this event is considered reportable.The monitron device was sent back to percussionaire for evaluation.The device was noted to have external damage that could not be confirmed to be related, but was fixed.The white screen was able to be replicated and confirmed that the root cause was related to the power circuit.It was also noted that the device had not been serviced in some time.The device was repaired and sent back to the customer.No patient harm was reported from this incident.If any follow up information is received on this event, a follow up mdr will be submitted.
Event or Problem Description
Per customer complaint, the monitron was unplugged while on and in use with a vdr ventilator on a patient.It was plugged into another outlet and the screen turned white and could not be reset.The system was replaced with another system.No patient harm was 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: 18580360
• Report Number: 3029845-2024-00026
• Device Sequence Number: 7021385
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2010
• 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