Device product
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
Z-1768-2017
Product summary
- Event
- Event 76723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 654 units total (230 units in US)
- Official record key
device-enforcement:Z-1768-2017
Official wording
Reason: The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Code information: Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232) Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software. Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.
Distribution pattern: Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand
Derived failure modes
-
Unknown
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.