MAUDE Adverse Event Report: PERCUSSIONAIRE VDR-4; VENTILATOR

Model Number	F00008-1
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received by a customer using a vdr-4 stating that while the device was being used on a patient, the device's secondary disconnect alarm failed to alarm.It was confirmed by ths customer that the alarm function was working properly during the pre-use check.No patient harm or injury was reported due to this failure.
Additional Manufacturer Narrative
This event is being reported, as there was a failure to a life-sustaining product while in use on a patient.The device was not returned for evaluation, and therefore no root cause for the malfunction was determined.No patient harm or injury was reported by the customer.If any additional information is obtained, or if the product is returned for evaluation, a follow-up mdr will be submitted to fda.

• Brand Name: VDR-4
• Common Device Name: VENTILATOR
• Manufacturer (Section D): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 20691535
• Report Number: 3029845-2024-00047
• Device Sequence Number: 15599498
• Product Code: CBK
• UDI-Device Identifier: 00849436000044
• UDI-Public: 00849436000044
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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