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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP MODULAR COOLER HEATER UNIT (MCH)

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CARDIOQUIP CARDIOQUIP MODULAR COOLER HEATER UNIT (MCH) Back to Search Results
Model Number MCH-1000
Patient Problems Death (1802); Pneumonia (2011)
Event Date 09/09/2016
Event Type  Death  
Event Description
Two pts who had surgery, later tested positive for legionaries pneumonia. During hospital's investigation into potential source, 3 operating room cooler-heater units tested positive for legionella bacteria. There has been no conclusive evidence at this time to link the pneumonia to the equipment.
 
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Brand NameCARDIOQUIP
Type of DeviceMODULAR COOLER HEATER UNIT (MCH)
Manufacturer (Section D)
CARDIOQUIP
3827 old college rd
bryan TX 77801
MDR Report Key5994706
MDR Text Key56540008
Report Number5994706
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/21/2016
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received09/22/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMCH-1000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/21/2016
Distributor Facility Aware Date09/05/2016
Device Age13 MO
Event Location Hospital
Date Report to Manufacturer09/21/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/22/2016 Patient Sequence Number: 1
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