FDA-Device2017-08-02Class I
CS 100i Intra-Aortic Balloon Pump
Maquet Datascope Corp - Cardiac Assist Division
Hazard
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Sold states
Worldwide Distribution - (in over 100 countries) US (Nationwide)
Affected count
12,319 units total
Manufactured in
1300 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
CS 100i Intra-Aortic Balloon Pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2736-2017Don't want to check this manually?
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