Philips IntelliVue MX Patient Monitor System-IntelliBridge Module EC10 Recall

What Happened

Philips Medizin Systeme Boblingen Gmbh has reported a potential safety issue involving the IntelliVue Patient Monitor (host monitor) when used with the IntelliBridge EC10 Module and EC5 ID-Module. The system may fail to trigger a “No Device Data” INOP alarm when interfacing with Hamilton ventilators, meaning clinicians might not be alerted if data transmission is interrupted.

Which Products Are Affected

The recall concerns the following product:

• Product Name: IntelliVue MX Patient Monitor System-IntelliBridge Module EC10
• Model/Catalog Number: 865115
• Serial Numbers: Not applicable

What You Should Do

Healthcare facilities using the affected IntelliVue modules with Hamilton ventilators should be aware of the potential for the system to fail to alarm during data loss. For specific guidance on mitigation or repair, users are advised to contact Philips Medizin Systeme Boblingen Gmbh or refer to the official Health Canada recall notice for further instructions.

Why This Matters

The failure of a patient monitoring system to provide an alarm during a loss of device data can lead to a lack of awareness regarding a patient’s physiological status. This delay in information could pose a significant risk to patient safety in clinical environments.

Source

Health Canada