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

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.

• Brand Name: CARDIOQUIP
• Type of Device: MODULAR COOLER HEATER UNIT (MCH)
• MDR Report Key: 6001295
• MDR Text Key: 56558681
• Report Number: 6001295
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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 Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-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 FDA: 09/21/2016
• Distributor Facility Aware Date: 09/05/2016
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR