| TGA Action ID |
RC-2026-RN-00690-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
LIFEPAK 35 Monitor/Defibrillator
Catalogue Numbers: 70335-000016, 70335-000017, 70335-000030, 70335-000018, 70335-000034
Distribution Dates: 27/06/2024 to 14/07/2026
Multiple serial numbers |
| ARTG Number |
452046 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Stryker has identified two (2) serial number specific problems which may impact the LIFEPAK 35 Monitor/Defibrillator (LP35). A device may potentially be impacted by one or both problems.
1. "CHECK RHYTHM / ECG Analysis Inconclusive" not displayed
When certain conditions are met, the device does not display the message "CHECK RHYTHM / ECG Analysis Inconclusive" as intended after inconclusinve cprINSIGHT result. The problem does not affect the display of "Shock Advised" or "No Shock Advised" messages, and therapy delivery remains available.
This could result in a delay in recognising the need to reassess the patient's rhythm and could contribute to a delay in defibrillation energy.
2. Printer and modem access ports
Certain printer and modem access port connectors may not have been fully seated within the rear housing assembly. If a connector is not fully seated, the environmental seal may be compromised, potentially reducing the device's ability to prevent ingress of water or dust.
If moisture enters the device through an improperly sealed access port, device performance could be compromised. Depending on the extent and location of the moisture ingress, the device could experience an inability to deliver therapy, a delay in therapy delivery, reduced pacing or synchronized cardioversion performance, loss of printing functionality, or interruption of data transmission capabilities.
To date, there have been no adverse event reports for either of these problems. |
| Instructions for Customers/Users |
"CHECK RHYTHM / ECG Analysis Inconclusive" not displayed
Customers are to:
• Confirm the Device Setup Option is configured with Manual Mode Voice Prompts ON
• If the Voice Prompts setting is OFF, follow the instructions in the customer letter to enable it.
This problem will be corrected through a software update.
Printer and modem access ports
Customers are to:
• Follow the Operating Instructions (OI) for use and avoid immersing any porting of the monitor/defibrillator in water or other fluids until the corrective action has been completed.
• Avoid spilling any fluids on monitor/defibrillator or accessories, as spilled liquids may cause the monitor/defibrillator and accessories to perform inaccurately or fail.
• If available, use a rear storage bag with the device.
This problem will be corrected through a hardware inspection and correction.
A Stryker representative will coordinate a site visit to complete the required correction(s) for affected product. |
| Action Commencement Date |
11/09/2026 |
| Responsible Entity |
|
| Contact Information |
postmarketssp@stryker.com - Stryker Australia |