Model note · Cardiac Monitor
Philips IntelliVue MX40 patient worn monitor
The IntelliVue MX40 is a small battery monitor that the patient wears. It is that sends its parameters and alarms to the PIIC iX central station over the 1.4 GHz WMTS Smart-hopping network. It can also act as a local monitor in Monitor Mode. It is for adults and children in hospital, including transport inside the hospital, and not for home use. Its recall record is almost all about alarms reaching people: a configuration that stopped ECG alarms reaching the central station, alarms that did not resume after a pause, weak speakers at altitude, and silent low battery states. 'No audible alarm' leads its MAUDE reports.
The model
Maker, model and type.
- Maker
- Philips Medical Systems
- Model
- IntelliVue MX40 patient worn monitor (865350 US, 865352 outside US)
- Device type
- Cardiac Monitor
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FDA classification and clearances | Physiological patient monitor with arrhythmia detection, 21 CFR 870.1025, Class II; product codes DSI, MHX, MLD, DRW, DQA, DSA, MSX, DRO; K103646 (7 January 2011) and K113125 (17 November 2011, updated lead set compatibility) | Source |
| Intended use | Monitoring, recording and alarming of multiple physiological parameters in adults and pediatrics in hospital and during transport inside hospitals; not for home use; health care professionals only | Source |
| Standards | IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC13 (cardiac monitors), ISO 9919 (oximetry), IEC 60601-2-25, EC53 (ECG cables and leadwires) | Source |
| Radio | IntelliVue WMTS Smart-hopping 1.4 GHz with access points and optional remote antennas (PN 867151) | Source |
| Battery | Lithium ion rechargeable battery REF 989803176201 (other battery types also used) | Source |
Recalls
Known FDA recalls.
- Z-1671-20212021-02-02
Process steps not followed in manufacturing; potentially defective units shipped.
FDA record - Z-2547-20192019-08-23
Remote antenna cable not rated for some installations.
FDA record - Z-1692-20192019-03-28
Increased power use and missing visual or audible low battery notifications.
FDA record - Z-1067-20192019-01-25
Lithium ion batteries with a possible manufacturing defect shipped in error.
FDA record - Z-0592-20192018-10-10
Speaker faint or silent above 4,500 feet in Monitor Mode (35,469 units).
FDA record - Z-0291-20172016-09-19
Configuration setting disables ECG alarms to PIIC iX (9,804 units).
FDA record - Z-1746-20142014-05-22
Software B.00 or B.01 may not resume alarming after a pause (42,600 units).
FDA record
Safety
Safety warnings from the record.
- A telemetry monitor is only safe if its alarms reach someone: a local setting change on some software stopped ECG alarms reaching the central station (9,804 units, 2016). Source
- In 2014, 42,600 units could stay silent after an alarm pause ended. Source
- Smart-hopping 1.4 GHz access points with certain firmware could lose signal for several minutes. Source
Sources
Where this note comes from.
- FDA 510(k) K113125 summary, Philips IntelliVue MX40 Patient Monitor
- openFDA device recall records for the MX40
- openFDA MAUDE problem counts for the IntelliVue MX40
Not covered: The MX40 instructions for use and service guide were not read, so parameter ranges, battery run times, screen details and the full INOP list are not included. The acceptance alarm test and the design note are BMEssentia advice drawn from the recall pattern, not Philips procedures.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.