BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL PROTECTION SYSTEM MPS2 CONSOLE

    MDR report key: 5763513 · Received June 30, 2016

    Report

    Report Number
    1649914-2016-00034
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Date of Event
    June 3, 2016
    Report Date
    July 1, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624521265
    PMA / PMN Number
    K041979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE COMPLAINANT ON 7/1/2016 FOUND THAT THE CONSOLE WAS NOT USED THE PROCEDURE. THE ALLEGED ISSUE (ERROR CODE FOR INTERNAL TIMING ERROR) WAS FOUND WHILE SETTING UP FOR THE PROCEDURE, SO ANOTHER CONSOLE WAS USED INSTEAD.

    Description of Event or Problem · 1

    THE HOSPITAL BIOMEDICAL ENGINEER REPORTED AN ISSUE WITH THE MPS-2 CONSOLE DURING USE. THE REPORT STATED THAT THE CONSOLE DISPLAYED AN ERROR CODE FOR "INTERNAL TIMING ERROR" AND HAD BEEN REMOVED FROM SERVICE. FOLLOW-UP ATTEMPTS WITH THE COMPLAINANT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT WERE UNSUCCESSFUL. THE CONSOLE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416973 MYOCARDIAL PROTECTION SYSTEM MPS2 CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 52012602063462452126520634624521265 20634624521265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention