BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET CARDIOHELP

    MDR report key: 4113696 · Received September 17, 2014

    Report

    Report Number
    8010762-2014-00349
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMERGENCY DRIVE IS BEING RETURNED TO THE FACTORY FOR EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EMERGENCY DRIVE ON THE DEVICE JAMMED DURING PREPARATION OF A NEW DISPOSABLE FOR REPLACEMENT. NO REPORTED PATIENT EFFECT SINCE PRIMING WAS ALREADY COMPLETE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575825 MAQUET CARDIOHELP CARDIOHELP DTQ MAQUET CARDIOPULMONARY AG 70104.8012

    Patients

    Seq Age Sex Outcome Treatment
    1