MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. IMPULSATOR; VENTILATOR

Model Number	S00010
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident is being re-evaluated as part of newly implemented procedures.As the device failed while in use on a patient, this event is deemed reportable.The device was sent back to percussionaire for evaluation and it was determined that a capacitor failed, causing a fuse to ultimately fail.The components were replaced and the device was tested.It was confirmed the device passed all functional tests and was sent back to end customer.No additional information was received on patient status; no patient harm reported.If any additional information is received on this event, a follow up mdr will be submitted.
Event or Problem Description
Per customer complaint, the impulsator at home therapy device was in use on patient, when it stopped working.It was stated by the caregiver that a fuse may have melted.No patient harm was stated in complaint.

• Brand Name: IMPULSATOR
• 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: 18573555
• Report Number: 3029845-2024-00020
• Device Sequence Number: 7922680
• 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: 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: 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: 11/08/2022
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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