Device product
Fetal Spiral Electrode, Model No. 9898 031 37631
Z-1250-2019
Product summary
- Event
- Event 82422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,971,925 (78,877 boxes)
- Official record key
device-enforcement:Z-1250-2019
Official wording
Reason: During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
Code information: All products currently in distribution.
Distribution pattern: Distributed nationwide within US. Worldwide international distribution.
Derived failure modes
-
Unknown
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.