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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(M)
Device Problems Device Emits Odor (1425); Shipping Damage or Problem (1570); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2016
Event Type  malfunction  
Manufacturer Narrative
This report is being submitted to replace report number mw5068335, submitted on 03/06/2017.
 
Event Description
The customer had called reporting the unit was not working properly, and that the nurse noted a "smell of smoke".The customer was sent a new unit, the unit in question was investigated and was found to have shipping damage.Upon further inspection of the unit, the manufacturer was unable to produce either the smell or the appearance of smoke from the unit.
 
Manufacturer Narrative
This report is being submitted to replace report number mw5068335, submitted on 03/06/2017.
 
Event Description
The customer had called reporting the unit was not working properly, and that the nurse noted a "smell of smoke".The customer was sent a new unit, the unit in question was investigated and was found to have shipping damage.Upon further inspection of the unit, the manufacturer was unable to produce either the smell or the appearance of smoke from the unit.
 
Manufacturer Narrative
The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The unit was still under warranty and a replacement unit was sent to the customer.Cardioquip service received the device and inspected the unit.The only component that was nonfunctioning was the screen.The screen was repaired, a final inspection was performed, and passed for full functionality.
 
Event Description
Customer reports the unit was not working properly, and the nurse noted a "smell of smoke.".
 
Manufacturer Narrative
The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The unit was still under warranty and a replacement unit was sent to the customer.Cardioquip service received the device and inspected the unit.The only component that was nonfunctioning was the screen.The screen was repaired, a final inspection was performed, and passed for full functionality.
 
Event Description
Customer reports the unit was not working properly, and the nurse noted a "smell of 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 Key6944361
MDR Text Key90846431
Report Number3007899424-2017-00002
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 Other,Company Representative
Reporter Occupation Biomedical Engineer
Remedial Action Replace
Type of Report Initial,Followup,Followup,Followup
Report Date 03/06/2017,06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMCH-1000(M)
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2017
Device Age6 MO
Event Location Hospital
Date Manufacturer Received01/29/2016
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? No
Type of Device Usage Unknown
Patient Sequence Number1
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