Device product
Capnostream20 (INTL) M REFURBISHED, CS78654
Z-0052-2019
Product summary
- Event
- Event 80895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-0052-2019
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: B300001467 B300001028 B300001013 B300001063 B300001239 B300001299 B300001432 B300001465 B300001233 B500001792 B500001690
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.