BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS2 CONSOLE

    MDR report key: 879246 · Received September 19, 2006

    Report

    Report Number
    1649914-2006-00091
    Event Type
    Malfunction
    Date Received
    September 19, 2006
    Date of Event
    August 10, 2006
    Report Date
    September 15, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PRIME, THE PUMP ALARMED ADDITIVE PUMP ERROR. THE UNIT WAS TURNED OFF AND THE USER CALLED THE SUPPORT LINE. ANOTHER PUMP WAS USED TO FINISH THE CASE. THE CUSTOMER REPORTED A BURNING SMELL, WHEN THE UNIT IS POWERED ON. FIELD SERVICE IS TRAVELING TO THE ACCOUNT. PRODUCT CODE 5201260.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS2 CONSOLE CARDIOPLEGIA DELIVERY SYSTEM-HARDWARE DTR QUEST MEDICAL, INC. 5201260 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR