Device product
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Z-0290-2024
Product summary
- Event
- Event 93013
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1022 units
- Official record key
device-enforcement:Z-0290-2024
Official wording
Reason: It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
Code information: UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.