MAUDE Adverse Event Report: QUEST MEDICAL, INC. MYOCARDIAL PROTECTION SYSTEM CONSOLE; CPBP HEAT EXCHANGER

Model Number	5001000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
Event or Problem Description
The hospital perfusionist reported an issue with the mps console during use.She reported that the console alarmed and displayed an error code for "internal timing error" during the induction dose of arrest agent.The report stated that the console displayed the error four times before remaining on.There were no patient complications reported as a result of the alleged issue.The console was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Evaluation of the returned console confirmed the reported issue.The motor driver board was found to be defective and was replaced.The console then successfully passed all verification testing and was released back for use.

• Brand Name: MYOCARDIAL PROTECTION SYSTEM CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6372922
• Report Number: 1649914-2017-00009
• Device Sequence Number: 13581073
• Product Code: DTR
• UDI-Device Identifier: 20634624501007
• UDI-Public: 20634624501007
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 5001000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 05/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention