MAUDE Adverse Event Report: PERCUSSIONAIRE VDR-4; VENTILATOR

Model Number	F00008-1
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to a malfunction of the vdr ventilator while in use on a patient, this event is deemed reportable.No patient adverse reactions were reported with this event.It was stated by the customer that the device was sent to a third party for evaluation, in which the same malfunctions were observed.Percussionaire is still pending internal formal investigation, as the device has yet to be returned.Therefore, there is no formal root cause to document at this time.If additional information is obtained from the customer or from the internal evaluation, a follow-up mdr will be submitted to fda.
Event or Problem Description
Percussionaire was notified on november 1 regarding a potential malfunction with a vdr ventilator.It was reported by the customer that the vdr was making unusual noises while in use on a patient.The vdr was closely monitored after this initial observation.Shortly after, it was noticed on the vdr monitor that the displayed pressure on the oscillatory cpap would stop oscillating and unexpectedly initiate a manual breath automatically.The pressure then rose into the 70s briefly, and then returned to the oscillatory cpap mode.The customer communicated that there was an audible increase in flow, which suggested the pressure was delivered to the patient.The device was then removed from the patient.The patient was confirmed to have no adverse reactions due to this event.

• 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: 20805839
• Report Number: 3029845-2024-00049
• Device Sequence Number: 21180119
• Product Code: CBK
• UDI-Device Identifier: 00849436000556
• UDI-Public: 00849436000556
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2024

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: S00018-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/1996
• 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