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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP LLC MCH-1000 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CARDIOQUIP LLC MCH-1000 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000
Device Problems Smoking (1585); Noise, Audible (3273); Excessive Heating (4030)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2019
Event Type  Malfunction  
Event Description

Patient alerted staff nurse there was a "pop" from the ecmo machine and the room smelled like smoke. The heater of the ecmo machine was extremely hot to the touch. Cardiac perfusionist called to bedside to remove the heater and replace with another one.

 
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Brand NameMCH-1000
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP LLC
3827 old college rd
bryan TX 77801
MDR Report Key9129328
MDR Text Key160378346
Report Number9129328
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 08/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/27/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCH-1000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2019
Event Location Hospital
Date Report TO Manufacturer09/27/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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