Device product
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
Z-1022-2015
Product summary
- Event
- Event 70068
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1022-2015
Official wording
Reason: If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.
Code information: SK514470022YA, SK514470023YA, SK514470024YA, SK514470020YA, SK514470021YA, SK514100003YA, SK514470019YA, SK514470001YA, SK514470017YA, SK514470018YA, SK514450021YA, SK514450022YA, SK514450019YA, SK514470004YA, SK514470005YA, SK514390001YA, SK514150002YA, SK514150004YA, SK514150005YA, SK514300002YA
Distribution pattern: Distributed in the US and Europe.
Derived failure modes
-
Unknown
If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.