Device product
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Z-1395-2022
Product summary
- Event
- Event 90457
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,210 units
- Official record key
device-enforcement:Z-1395-2022
Official wording
Reason: Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.
Code information: UDI-DI- 10381780533778; All serial numbers.
Distribution pattern: Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.
Derived failure modes
-
Unknown
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.