MAUDE Adverse Event Report: PERCUSSIONAIRE IPV 1C; NONCONTINUOUS VENTILATOR

Model Number	F00001-C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pneumothorax (2012)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, customer service was notified of an adverse event that occurred at (b)(6) hospital.On (b)(6) 2024, a respiratory therapist was providing ipv therapy to a patient via in-line connection on a mechanical ventilator with an ipv 1c device and did not see the normal chest wiggle expected on the patient.It was stated the blue cap was present on the expiratory port of the phasitron breathing circuit at this time.The respiratory therapist decided to perform the therapy directly through the patient's artificial airway and did not remove the blue cap from the phasitron circuit.It was reported that after about 5 seconds of connection, the patient immediately started thrashing and vomited.The patient was removed from the therapy and placed back on the ventilator.The patient went into cardiac arrest and required chest compressions to return to a stable state.It was later found through a chest x-ray that the patient developed a bilateral pneumothorax.
Additional Manufacturer Narrative
This mdr is being reported due to the patient requiring additional intervention post cardiac arrest, as well as experiencing a bilateral pneumothorax.The device was not sent back to sentec for proper evaluation.However, through communication of customer service with a (b)(6) hospital representative, it was determined that the cause of the adverse event was the failure to remove the blue cap from the phasitron breathing circuit expiratory port when providing therapy through the patient's artificial airway.The ipv 1c instructions for use provides a warning to remove the blue cap when providing therapy directly to the patient's mouth, mask, or endotracheal tube.The blue cap is only used on the breathing circuit expiratory port when the therapy is being given in connection with an in-line valve.This event is being concluded as user-induced.No additional information has been provided on the patient at this time.The instructions for use is currently being assessed for blue cap use clarity.If any additional information becomes available on this event, a follow-up mdr will be submitted to fda.

• Brand Name: IPV 1C
• Common Device Name: NONCONTINUOUS 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: 19654852
• Report Number: 3029845-2024-00037
• Device Sequence Number: 15179581
• Product Code: NHJ
• UDI-Device Identifier: 00849436000020
• UDI-Public: 00849436000020
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: F00001-C
• Device Catalogue Number: S00002-C
• 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: 06/03/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening
• Patient Age: 4 YR
• Patient Sex: Male