MAUDE Adverse Event Report: PERCUSSIONAIRE IMPULSATOR; VENTILATOR, NON-CONTINOUS

Model Number	F00012
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is being re-evaluated in 2024 due to newly implemented procedures.As the device failed while in use on a patient, causing doubt in accurate ventilation care, this event is deemed reportable.The device was evaluated at percussionaire and it was determined that the device malfunction was in relation to a cartridge failure.Once the cartridge was replaced, the device functioned appropriately.No additional information was received on the patient status.No patient harm or injury was reported.If any additional information is made available, a follow up mdr will be filed.
Event or Problem Description
Per complaint received by the customer, while in use on the patient, the caregiver noted that the device would not percuss/rovide required therapy until it reached 28 psi.

• Brand Name: IMPULSATOR
• Common Device Name: VENTILATOR, NON-CONTINOUS
• 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: 18699247
• Report Number: 3029845-2024-00033
• Device Sequence Number: 7352455
• Product Code: NHJ
• UDI-Device Identifier: 00849436000389
• UDI-Public: 00849436000389
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K905236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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: F00012
• Device Catalogue Number: S00010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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