MAUDE Adverse Event Report: CARDIOQUIP, LP CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER; HYPO/HYPERTHERMIA UNIT

Model Number MCH-1000

Device Problems Electrical /Electronic Property Problem (1198); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2017

Event Type  malfunction  

Event Description

Unit shutting off breaker, condensation inside of device drips onto wiring.Estimated current leakage was 1300 microamps.Unit removed from service.Vendor called in and repaired unit.

• Brand Name: CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER
• Type of Device: HYPO/HYPERTHERMIA UNIT
• Manufacturer (Section D): CARDIOQUIP, LP; 3827 old college road; bryan TX 77801
• MDR Report Key: 6934776
• MDR Text Key: 88850783
• Report Number: 6934776
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• 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: 09/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1