Device product
IntelliVue Patient Monitor MX400. Model Number: 866060
Z-1107-2025
Product summary
- Event
- Event 96138
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-1107-2025
Official wording
Reason: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Code information: Model Number: 866060. UDI-DI Number: (01)00884838038752(21). Serial Numbers: DE35174105, DE35174084, DE35174083, DE35174082, DE35174080, DE35107369, DE35108320, DE35160410, DE671M4116, DE7770DA9W, DE35114616, DE35114618, DE671E8921, DE671E8917, DE7580AH50, DE7580AHEH, DE35123130, DE671V9297, DE671V9296, DE671V9298, DE35160989, DE35160994, DE35160988, DE35161272, DE35161273, DE35161274, DE7580B537, DE7580B52H.
Distribution pattern: US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.
Derived failure modes
-
Unknown
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.