BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS MYOCARDIAL PROTECTION SYSTEM CONSOLE

    MDR report key: 5265661 · Received December 3, 2015

    Report

    Report Number
    1649914-2015-00106
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Date of Event
    November 4, 2015
    Report Date
    November 4, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624521265
    PMA / PMN Number
    K041979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A QUEST MEDICAL INC FIELD SERVICE ENGINEER (FSE) TRAVELED TO THE LOCATION TO EVALUATE THE CONSOLE. THERE WERE NO ISSUES FOUND WITH THE CONSOLE AND IT WAS FOUND TO BE IN WELL-MAINTAINED CONDITION. THE COMPLAINT CONDITION COULD NOT BE DUPLICATED OR CONFIRMED. 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.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE MPS2 CONSOLE DURING A PROCEDURE. THE SURGEON HAD STATED THAT THE HEART WAS "NOT ACTING RIGHT." FOLLOW UP WITH THE SURGEON FOUND THAT THERE WAS IRREGULAR MOVEMENT IN THE HEART DURING A STAGE IN THE PROCEDURE WHEN IT SHOULD HAVE BEEN STILL. THE PERFUSIONIST STATED THAT AFTER THE PROCEDURE HE HAD PERFORMED A VOLUMETRIC ACCURACY TEST AND A COOLING PERFORMANCE TEST WITH NO PROBLEMS FOUND. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. A QUEST MEDICAL INC. FIELD SERVICE ENGINEER TRAVELED TO THE HOSPITAL TO EVALUATE THE CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796143 MPS MYOCARDIAL PROTECTION SYSTEM CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5201260 20634624521265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention