BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 MYOCARDIAL PROTECTION SYSTEM CONSOLE

    MDR report key: 5352016 · Received January 7, 2016

    Report

    Report Number
    1649914-2015-00117
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    December 7, 2015
    Report Date
    January 4, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    20634624521265
    PMA / PMN Number
    K041979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MECHANISM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. BOTH THE CAM_56 AND CAM_1234 CIRCUITS WERE FOUND NOT FUNCTIONAL. THEY WERE NOT SHORTED; THE HIP CHIP'S OUTPUTS WERE NOT CORRECT. THE MOTOR DRIVER BOARD WAS REPLACED. 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

    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 PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH THE MPS 2 CONSOLE. THE REPORT STATED THE CONSOLE DISPLAYED AN ALARM ("HIGH INLET PRESSURE") DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THE CONSOLE WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10386 MPS2 MYOCARDIAL PROTECTION SYSTEM CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5201260 20634624521265

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention