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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP MODULAR COOLER-HEATER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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CARDIOQUIP LLC CARDIOQUIP MODULAR COOLER-HEATER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number MCH-1000
Device Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2020
Event Type  malfunction  
Event Description
Healthcare provider smelled "burning" and noted smoke coming from the heater/cooler component of the ecmo machine. Fda safety report id# (b)(4).
 
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Brand NameCARDIOQUIP MODULAR COOLER-HEATER
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
CARDIOQUIP LLC
MDR Report Key9763921
MDR Text Key181719694
Report NumberMW5093338
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMCH-1000
Device Lot Number6/19
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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