BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW SPANISH EU-PLUG ICU

    MDR report key: 4698363 · Received April 14, 2015

    Report

    Report Number
    8010762-2015-00365
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    July 13, 2014
    Report Date
    March 20, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION ARRIVED AT MAQUET (B)(4) ON 2014-04-10. INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL - MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A HEAD ERROR WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247394 ROTAFLOW SPANISH EU-PLUG ICU DTQ DTQ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1