Device product
Capnostream20 (INTL) M W/PRINTER, CS08660
Z-0047-2019
Product summary
- Event
- Event 80895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-0047-2019
Official wording
Reason: The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Code information: B300001031 B300001047 B300001049 B300001052 B300001065 B300001453 B300001454 B300001468 B300001130 B300001325 B500001762 B500001843 B500001892 B500001915 B500001945 B500002146 B500002103 B500002150 B500002132 B502123108 B523123180 B523123182 B523123186
Distribution pattern: The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
Derived failure modes
-
Unknown
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.