MAUDE Adverse Event Report: PERCUSSIONAIRE IPV-2C; NONCONTINUOUS VENTILATOR

Model Number	F00002-C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pneumothorax (2012)
Date of Event	11/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
This event is being reported due to patient death.Based on the details provided from the sentec representative's communications with the hospital, the root cause of this event is assumed to be related to the critical state of the patient's condition and their comorbidities, in combination with the failure to remove the in-line valve blue cap from the phasitron circuit expiratory port prior to providing therapy directly to the patient's airway.The amount of time the patient underwent the ipv therapy is unclear, however, it was stated that the patient experienced a pneumothorax prior to passing away.Percussionaire initiated a field safety corrective action (fsca) for the in-line valve blue cap misuse in september 2024 (1000524541-08/21/2024-001-c).All impacted customers were provided notification of this issue, updated instructions for use with updated warnings and images for proper blue cap use, as well as cautionary labels to be placed on customer's in-line valve inventory.A warning was already included in the previous revision of the instructions for use to ensure blue cap was removed prior to direct airway use; this warning was updated for clarity to state the breathing circuit expiratory port should remain open at all times.The caution labels provided to customers detailed proper use of the in-lin valve, with a prompt to keep the phasitron expiratory port open at all times.All hospitals received labels and a hard copy of the fsca notification.Percussionaire communicated to reach out if additional cautionary labels were needed.It was confirmed that elliot hospital received multiple emails about this fsca, as well as the shipped labels and a hard copy of the fsca notification.Percussionaire is attempting to gather any additional information.If additional information is obtained, a follow-up mdr will be submitted.
Event or Problem Description
On november 1st, a sentec representative was made aware of a patient death after use of an ipv-2c device.The respiratory therapy staff communicated that the patient was a critically ill adult with many comorbidities, and thus was complex to treat, and extremely difficult to ventilate.Additionally it was stated due to the patient's comorbidities, they likely would have succumbed to their conditions with or without administering ipv therapy in any setup (in-line or direct to et tube).The patient was stated to be on a ventilator but removed from the ventilator to provide the ipv treatment.The ipv treatment was administered through the patients et tube directly.Through additional communications from the sentec representative and hospital staff, it was stated that the expiratory port of the phasitron was occluded with the in-line valve blue cap.The patient experienced a pneumothorax; multiple attempts were made to revive the patient, however, the patient ultimately passed away.The amount of time the patient was set up with the ipv treatment and settings used were unable to be confirmed.

• Brand Name: IPV-2C
• 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: 20805843
• Report Number: 3029845-2024-00050
• Device Sequence Number: 21180121
• Product Code: NHJ
• UDI-Device Identifier: 00849436000037
• UDI-Public: 00849436000037
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: F00002-C
• Device Catalogue Number: S00003-C
• Was Device Available for Evaluation?: No
• 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
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1000524541-08/21/2024-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown