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U.S. Department of Health and Human Services

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

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CARDIOQUIP MODULAR COOLER HEATER UNIT (MCH) Back to Search Results
Model Number MCH-1000
Device Problem Contamination (1120)
Patient Problem Pneumonia (2011)
Event Date 08/08/2016
Event Type  Injury  
Event Description
Two patients who had surgery, later tested positive for legionnaire's 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)
MDR Report Key6001295
MDR Text Key56558681
Report Number6001295
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2016
Is this an Adverse Event Report? No
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?
Is the Device Single Use?
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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