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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP HEATER-COOLER

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CARDIOQUIP LLC CARDIOQUIP HEATER-COOLER Back to Search Results
Model Number MCH-1000
Device Problems Naturally Worn (2988); Insufficient Information (3190)
Patient Problem Alteration in Body Temperature (4568)
Event Date 07/20/2020
Event Type  Malfunction  
Event Description

The extracorporeal membrane oxygenation (ecmo) heater clicked into test mode during cannulation. Water was added and seemed to be functioning appropriately at that time. About an hour later, it was noted that the heater temperature was 30 degrees celsius and the patient's temperature decreased. The heater was exchanged with another and sent to our biomedical engineering team to investigate.

 
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Brand NameCARDIOQUIP
Type of DeviceHEATER-COOLER
Manufacturer (Section D)
CARDIOQUIP LLC
8422 calibration ct
college station TX 77845
Manufacturer (Section G)
CARDIOQUIP LLC
8422 calibration ct
college station TX 77845
Manufacturer Contact
melanie harry
8422 calibration ct
college station, TX 77845
9796910202
MDR Report Key10591355
MDR Text Key208753299
Report Number3007899424-2020-00007
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 USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Repair
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCH-1000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/30/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/27/2020 Patient Sequence Number: 1
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