IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
This recall involves updating instructions for using these devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
Product Name: Phasitron 5 In-Line Valve
Unique Device Identifier (UDI) and Part Number: 00849436000723, P5-TEE-20 (pack of 20)/ P5-Tee (individual)
Potential Lots Affected #: 240620, 240610, 240418, 240326, 230612, WO07066, WO07010, WO06020, WO05019, WO04884, WO04827, WO04756, WO04714, WO04656, WO04625, WO04596, WO04553, WO04398, WO04356, WO04061, WO03846, WO03748, WO03688
What to Do
- Follow updated use instructions and labeling.
- Remove the cap on the expiratory port when providing therapy directly to a patient’s airway using the mouth, a mask, or when directly connected to an endotracheal or tracheostomy tube.
On September 3, 2024, Sentec/Percussionaire sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
- Review updated instructions for proper in-line use and updated instructions for use (IFU) as follows:
- The blue cap provided with the P5-TEE is to be used as a protective cap ONLY. The protective cap is only to be placed on the in-line valve (P5-TEE) Phasitron 5 port connection when therapy is not being provided to prevent any particles from entering the valve.
- The Phasitron 5 expiratory port should remain open and unobstructed when giving treatment.
IMPORTANT NOTE: These updated instructions differ from the prior IFU (P20020 Rev E).
- Revise institutional protocols and procedures related to use of the P5-TEE as necessary based on the updated instructions and labeling.
- Print and post updated instructions for proper In-Line Valve use throughout the facility.
- Communicate and train primary users of IPV therapy using the updated instructions for proper use.
- Re-label current product by placing the sticker provided by Percussionaire on each individual P5-TEE bag on stock (stickers provided via mail).
- Complete and return acknowledgement form included with the letter by September 27, 2024.
Reason for Updates to Use Instructions
Sentec/Percussionaire is updating use instructions for the Phasitron 5 In-Line Valve due to an increase in reports of patient injuries after users failed to remove the blue plug from the expiratory port when applying therapy directly to a patient’s airway. Failure to remove this cap during direct airway therapy can lead to the patient receiving too much pressure from the ventilator.
The use of affected product without following updated instructions may cause serious adverse health consequences, including heart attack (cardiac arrest), air entering the space between the lung and the chest wall (pneumothorax), an airway (tracheobronchial) tear and death.
There have been six reported injuries. There have been no reports of death.
Device Use
The Intrapulmonary Percussive Ventilation (IPV) Phasitron 5 In-Line Valve is part of the Phasitron 5 system that provides IPV therapy to patients who are receiving mechanical ventilation to help them breathe. This type of therapy can improve gas exchange and help keep the airways clear during ventilation.
Contact Information
Customers in the U.S. with questions about this recall should contact Sentec/Percussionaire customer service at FSCA@sentec.com.
Additional FDA Resources
- FDA’s Enforcement Reports
- Medical Device Recall Database Entries
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.