Device product
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.
Z-0292-2018
Product summary
- Event
- Event 78736
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7071
- Official record key
device-enforcement:Z-0292-2018
Official wording
Reason: Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
Code information: Model #: M300IA/AL, M3002A, M8102A, M8105A with ECO FW revision E.0 1.22 and 12-lead option C#12 Lots #s included on Consignee list Catalog #: 862442 (M3001A), 866462 (M3001AL), 865039 (M3002A), 865040 (M8102A), 865024 (M8105A)
Distribution pattern: Worldwide Distribution and US Nationwide
Derived failure modes
-
Unknown
Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors