MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. IMPULSATOR; VENTILATOR

Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the end user experienced a drop in oxygen and required emergency service attention after using a percussionaire product, this incident is deemed reportable.After multiple attempts to obtain the product, percussionaire was unable to receive the product back for investigational purposes.Due to this, no root cause can be determined for this incident.No additional information has been received by the end user on patient status.If any additional information is received, a follow up mdr will be filed.
Event or Problem Description
Per complaint received from the customer, while providing treatment to the customer's child at home, the user smelled a burnt plastic smell coming from the device.Post treatment, the customer noticed their child's oxygen level dropped severly, requiring the need to call for emergency medical services.During a second treatment, occurring the following day, the customer noticed their child's oxygen level dropped again.No additional information has been received for this incident.

• 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: 18573321
• Report Number: 3029845-2024-00011
• Device Sequence Number: 7923667
• Product Code: CBK
• UDI-Device Identifier: 00849436000389
• UDI-Public: 00849436000389
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown