Device product
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Z-1746-2014
Product summary
- Event
- Event 68349
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,600
- Official record key
device-enforcement:Z-1746-2014
Official wording
Reason: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.
Code information: Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431
Distribution pattern: United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon
Derived failure modes
-
Device software or design
software revisions B.00 or B.01 may