| TGA Action ID |
RC-2026-RN-00626-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Percussionaire IPV Systems
IPV Systems (IPV 1; IPV-1C; IPV-2C; Impulsator; Travel Air; IPV-HC)
Product Numbers: S00065, S00002-C, S00003-C, S00010, S00055, S00009, P5/P5-10, P5-UC, P5-HC, P5-TEE |
| ARTG Number |
485994, 487525, 518429 |
| Unique Device Identifier (UDI) |
00849436000679, 00849436000020, 00849436000037, 00849436000389, 00849436000242, 00849436000358, 00849436000501, 00849436000525, 00849436000686, 00849436000723 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Percussionaire Corporation has recently received a complaint regarding the use of IPV therapy administered in-line to a mechanically ventilated, sedated patient receiving volatile anaesthetic agents using a Sedaconda system. In this event, the patient's sedation was reduced during concomitant use of the two therapies, resulting in reduced depth of sedation. Percussionaire is updating the Instructions for Use to warn users of use of IPV therapy in conjunction with any method of volatile anaesthetic administration, as concomitant use may interfere with anaesthetic delivery and pose a risk of patient harm.
To date, Percussionaire has received one reported adverse event related to this problem, in which the patient experienced reduced sedation, necessitating cessation of IPV therapy to prevent the occurrence of serious adverse effects. |
| Instructions for Customers/Users |
• Percussionaire is updating the product Instructions for Use to include a warning about using IPV therapy with volatile anaesthetic systems.
• Customers are to review the new warning statement for IPV devices.
• Customer training will be updated to include a warning about using volatile anaesthetic systems in combination with IPV. |
| Action Commencement Date |
21/08/2026 |
| Responsible Entity |
|
| Contact Information |
02 7254 2160 - Percussionaire/Sentec |