BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3587186 · Received January 10, 2014

    Report

    Report Number
    8010762-2014-00014
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    December 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET SERVICE TECHNICIAN DETERMINED THE PRESSURE MODULE TO BE DEFECTIVE. THE PRESSURE MODULE WAS REPLACED. THE DEVICE IS STILL UNDER EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE ARTERIAL PUMP ON THE HL20 FAILED AND STOPPED ROTATING. THE PUMP COULD NOT BE RELEASED FROM THE SYSTEM CONTROL PANEL SO THE CUSTOMER STARTED TO HAND CRANK INSTEAD OF USING THE "FREE MODE" FOR EMERGENCIES. THE CUSTOMER THAN SWITCHED THE DEVICE AND CONTINUED THE INTERVENTION. NO REPORTED PT EFFECTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18353 MAQUET CARDIOPULMONARY AG HL 20 5-PUMPS CONSOLE BASE DTQ MAQUET CARDIOPULMONARY AG 70104.3267 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention