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

Model Number	F00008-1
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.Due to the customer stating the malfunction occurred during required ventilation, this incident is deemed reportable.The customer stated the device was not delivering oxygen to the patient.A oxygen analyzer was placed on teh device and no reading was available.The device was returned to percussionaire and investigated.The root cause was determined to be a nut used in the oxygen blender was not fastened as tightly as it should have been.It is unknown how it came loose.Once tightened, the device was confirmed to be working accordingly and passed all functional testing.No additional information on the patient or event has been received.If any additional "information" is obtained, a follow up mdr will be filed.
Event or Problem Description
Per customer feedback, a vdr ventilator failed while in use on a patient.It was stated by the customer that no oxygen was being delivered to the patient.No patient injury or harm was 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: 18573398
• Report Number: 3029845-2024-00015
• Device Sequence Number: 8902960
• Product Code: CBK
• UDI-Device Identifier: 00849436000044
• UDI-Public: 00849436000044
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Remedial Action: Repair
• 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: F00008-1
• Device Catalogue Number: S00018-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• 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