URGENT Field Safety Notice

INTELLIVUE MX40 PATIENT MONITOR

This document contains important information for the continued safe and proper use of your equipment.

Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.

Please retain this letter for your records.

Dear Customer,

This Field Safety Notice is to remind customers to review the information in the IntelliVue MX40 Instructions for Use (IFU) on how to use Standby mode and to explain under what circumstances, use of, or exposure to the device may pose a risk of harm. The notification alerts users of the associated risk of using Standby mode and steps to be taken to reduce or eliminate the risk.

Figure 1 – MX40 device

The IntelliVue MX40 patient monitor displays vital signs such as heart rate and oxygen saturation.

What's the problem

When the MX40 is in Standby mode for an extended period without patient surveillance, no monitoring or alarming is available because alarms, as designed, cannot be triggered when the MX40 is in Standby mode.

When users place the MX40 device in Standby mode, there are two possible outcomes:

1. If a timed duration (e.g., 10 minutes to 4 hours) is used for Standby, the MX40 will automatically resume monitoring and end Standby mode at the end of the time period.
2. If Infinite duration is used for Standby mode, the device will not resume monitoring until Standby is manually ended by the user or a "Tele Battery Low" INOP condition occurs.

While the MX40 device is in Standby, physiological monitoring and alarming is stopped.

Therefore, a hazardous situation may be present if a user places an MX40 in Standby longer than intended for completion of a patient procedure or test, and the device is not taken out of Standby. Philips has received three field reports about patient deaths:

1. Device in Standby and no alarm sounded; patient was DNR (Do Not Resuscitate); product working as intended; use error.
2. Customer had questions about Standby and retrospective patient information; no allegation of device malfunction; use error.
3. Device in Standby and no alarm sounded; product working as intended; use error.

Product was used according to labeled instructions; however, complaints were the result of use error. Users placed their MX40 devices in Infinite (Manual) Standby (or a Standby duration longer than the patient's expected test or procedure). After reconnecting the patient to the MX40, users did not manually resume the device from Standby, leading to missed critical alarms and delay in treatment.

Affected products and how to identify them

Hazard/harm associated with Standby mode

If a device in Standby mode is connected to a patient, it will not monitor or alarm, which may cause a delay in treatment if the patient's condition deteriorates. The immediate health consequences that may result from use of or exposure to the device include:

• No health consequences in the event the patient is stable and there is no event warranting further treatment during the timeframe the device is in Standby.
• Delayed detection of cardiac arrhythmias.
• Delayed detection of respiratory distress or hypoxia.
• Death.

The long-term health consequences that may result from use of or exposure to the device may include:

• Organ or brain damage in the event the patient is hypoxic and detection is delayed.

Actions that should be taken by the customer / user in order to prevent risks for patients or users

Please refer to the instructions in the IFU before using standby mode, see Sections: Standby Behavior, Unit Configurable Settings and Global Settings.

You can also find information about Standby mode from the PIC iX online Help. Click on the ? in any sector. Type "Standby" on the search field for more information.

In addition to the above, when the device is in Standby mode, a Standby mode screen is provided for a configured period at the MX40, including information describing how to resume monitoring from Standby mode. The duration of this screen can be configured by the user, with options between 1 and 30 minutes. The default time configuration for display of this screen is 1 minute. This provides information to the clinician that monitoring is not active. The MX40 is designed to be used with the Patient Information Center iX central monitor, which also indicates that the device is in Standby. The sector displays a message: "Standby. Click to Resume".

• To resume monitoring from Standby mode, press the blue Main Screen Button or disconnect/reconnect the MX40 patient cable.
• If the MX40 is placed in a timed Standby mode duration (i.e., not Infinite), a Standby mode timer is displayed on the MX40 screen. If in infinite Standby mode, the Standby message is always displayed until the device sleeps. Remember, when the device has been placed in Standby mode without the user choosing a time for when monitoring will resume (i.e., after 10, 20, 30 minutes or 1, 2, 3, or 4 hours), the device will remain in Standby mode until the user manually resumes monitoring, thereby ending Standby mode.
• Note that the Standby mode time may differ between the MX40 and the default setting at the Patient Information Center iX central monitor. The duration is determined by the location of the Standby selection, i.e., placing the MX40 in Standby mode at the device or at the Information Center iX. When the MX40 comes out of Standby mode at either location, the device is activated and monitoring resumes at both locations.
• This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially the MX40 devices have been transferred.

Actions taken by Philips in order to prevent risks for patients or users

Philips is distributing this URGENT Medical Device Correction to the affected customers / users.

If you need any further information, please contact your local Philips representative:

Telephone: 80303035

Email: philips.service@philips.com

Sincerely,

Hauke Schik
Head of Quality

Customer Response Form

Reference: CR # 2023-CC-HPM-014, Intellivue MX40 Patient Monitors

Instructions: Please complete and return this form to Philips promptly and no later than 3 days from receipt. Completing this form confirms receipt of the URGENT Field Safety Notice letter, understanding of the issue, and required actions to be taken.

Customer/Consignee/Facility Name: _________________________

Street Address: _________________________

City/State/ZIP/Country: _________________________

Customer Actions:

• Please refer to the instructions in the IFU before using standby mode, see Sections: Standby Behavior, Unit Configurable Settings and Global Settings.
• Review the contents of this letter with your staff.
• Pass this notice to all those who need to be aware within your organization or to any organization where the potentially the MX40 devices have been transferred.

We acknowledge receipt and understanding of the accompanying URGENT Field Safety Notice letter and confirm that the information from this Letter has been properly distributed to all users that handle the Intellivue MX40 Patient Monitors.

Name of person completing this form: _________________________

Signature: _________________________

Printed Name: _________________________

Title: _________________________

Telephone Number: _________________________

Email Address: _________________________

Date (DD / MMM / YYYY): _________________________

Please email this completed form to Philips at: FCO.Nordic@philips.com