MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. VDR-4; VENTILATOR

Model Number	S00018-1
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.Due to the device is considered to be a life sustaining device and the patient experiencing a drop in their oxygen levels, this report is deemed reportable.The patient also required unanticipated medical intervention, in which the patient was moved to another ventilator in order to continue required ventilation.The device was returned to percussionaire and underwent evaluation.The noted blender alarm notification could not be replicated when evaluated.At the time of evaluation, no root cause was determined; the device was confirmed to be functioning appropriately.No additional information was received on the incident or patient status.Any additional information will be filed with fda as a follow up mdr.
Event or Problem Description
Per customer complaint received, while the patient was using the vdr device for ventilation, the patient experienced desat.The blender alarm sounded.The respiratory therapist also noticed the vent pressure decreasing.The patient was moved to another ventilator.No patient harm reported.

• Brand Name: VDR-4
• Common Device Name: VENTILATOR
• 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: 18576305
• Report Number: 3029845-2024-00021
• Device Sequence Number: 7852355
• Product Code: CBK
• UDI-Device Identifier: 00849436000044
• UDI-Public: 00849436000044
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S00018-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2018
• 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