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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP MCH-1000(M)

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CARDIOQUIP LLC CARDIOQUIP MCH-1000(M) Back to Search Results
Device Problems Melted (1385); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2020
Event Type  Malfunction  
Event Description

The device was set up for an ecmo procedure on a patient. Within 2 minutes of beginning the procedure, the or staff began to notice smoke emanating from the mch device.

 
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Brand NameCARDIOQUIP
Type of DeviceMCH-1000(M)
Manufacturer (Section G)
CARDIOQUIP LLC
8422 calibration ct
college station, tx
Manufacturer Contact
melanie harry
8422 calibration ct
college station, tx 
6910202
MDR Report Key10094069
MDR Text Key207360818
Report Number3007899424-2020-00003
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Repair
Type of Report Initial
Report Date 04/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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