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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE
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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER HEATER; CARDIOPULMONARY BYPASS DEVICE Back to Search Results
Model Number MCH-1000(R)
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
The customer notified cardioquip that a patient was involved during the malfunction although no patient information was communicated.Cardioquip's investigation determined that a loose wire on the time delay relay caused electrical arcing.The electrical arcing then caused the smoke and burn damage seen in the device.A fully functional replacement device was sent to the customer.
 
Event Description
User reported that while the device was on a patient, maintaining 37 degrees, and the cpg was turned on, the rm began to smoke.
 
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Brand Name
CARDIOQUIP MODULAR COOLER HEATER
Type of Device
CARDIOPULMONARY BYPASS DEVICE
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
charley ford
8422 calibration ct.
college station, TX 77845
9796910202
MDR Report Key15839550
MDR Text Key305539552
Report Number3007899424-2022-00159
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 11/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMCH-1000(R)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2022
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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