FDA Device

MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up

Hazard

It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of bl

What You Should Do

Remedy

MAQUET sent an Urgent Medical Device Field Correction letters dated March 7, 2013 via Federal Express to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers are asked to complete and submit the included Customer Fax-back Form. Maquet Service will exchange all affected products with the updated version. For questions MAQUET Customer Service at 888-627-8383 (press option 2, followed by option 2).

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Products

MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood thro
Brand
Maquet Cardiovascular, LLC
UPC
Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.

Units Affected

154 units affected

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