Device product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Z-1836-2020
Product summary
- Event
- Event 85166
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1836-2020
Official wording
Reason: Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Code information: Serial Numbers: 902-754R2692N002 and 902-754R2692N001
Distribution pattern: US: in the state of California
Derived failure modes
-
Unknown
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.