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U.S. Department of Health and Human Services

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

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CARDIOQUIP, LP MCH-1000 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2018
Event Type  Malfunction  
Event Description

Cardioquip heater/cooler unit for cardiopulmonary bypass began to alarm. Gave "temp " error alarm. Attempted to reset, unable to do so switched out unit. Called company, tech being dispatched.

 
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Brand NameMCH-1000
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP, LP
3827 old college rd
bryan TX 77801
MDR Report Key7658377
MDR Text Key113023207
Report Number7658377
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMCH-1000
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2018
Event Location OPERATING ROOM
Date Report TO Manufacturer07/03/2018
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?
Type of Device Usage

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