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

Model Number	F00008-1
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer complaint, while the device was in use on a patient, it was stating the ventilator device was not functioning correctly, as well as not displaying accurate patient data.The patient was stated to be stable and not compromised.
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.Due to the vdr ventilator, a life sustaining device, malfunctioning while in use on a patient, this incident is deemed reportable.As stated by the customer, the vdr was not working accurately and the monitron display was reading incorrectly.The patient was stated to be stable at the time of the incident.The system was sent back to percussionaire for evaluation.It was found that the cpap/peep knob was not completely turned off at the full clockwise position.This is assumed to be why the end user was not interpreting data accordingly.The cpap/peep valve seemed to have been misaligned and was corrected at the manufacturing site during investigation.It was noted that the device was fully functioning and the cpap/peep valve was able to turn off at a full clockwise position prior to customer release 6 months prior.It is unknown how the valve was manipulated.At this time, no other information is available on the incident or patient.

• 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: 18579916
• Report Number: 3029845-2024-00025
• Device Sequence Number: 20617808
• Product Code: CBK
• UDI-Device Identifier: 00849436000044
• UDI-Public: 00849436000044
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection
• 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
• Device Model Number: F00008-1
• Device Catalogue Number: S00018-1
• Device Lot Number: VDR4M00407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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