BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET W AA

    MDR report key: 4012981 · Received July 10, 2014

    Report

    Report Number
    1649914-2014-00037
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 13, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC., HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL INC., DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REF MANUFACTURER REPORTS 1649914-2014-00035 AND 00036.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404042 MPS DELIVERY SET W AA CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0464434M05

    Patients

    Seq Age Sex Outcome Treatment
    1