Device product
Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 453564615351 453564615371 453564467761 (Korea) 453564467781 (Korea) 453564451791 (Japan, Taiwan, Indonesia) 453564451811 (Japan, Taiwan, Indonesia) 453564467821 (Mexico) 453564467841 (China) 453564467861 (China) Worldwide except for the USA SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals
Z-0292-2017
Product summary
- Event
- Event 75209
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1824 units
- Official record key
device-enforcement:Z-0292-2017
Official wording
Reason: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Code information: SW Revisions: B.05.28, B.05.29, and B.05.32
Distribution pattern: Worldwide Distribution-US (Nationwide) and countries of: Aruba, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Singapore, Slovenia, South Africa, Spain Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
Derived failure modes
-
Unknown
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX