BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPULMONARY DEVICE

    MDR report key: 2143616 · Received June 3, 2011

    Report

    Report Number
    2248146-2011-00338
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) NOTIFIED MAQUET REP OF A DEFECTIVE PLEGIOX. HE SAID THAT THERE WAS A WATER LEAK ON THE PLEGIA INTO THE BLOOD FROM THE DEFECTIVE HEAT EXCHANGER. IT WAS CAUGHT DURING THE PRETEST DURING PRIME SO NOT PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOPULMONARY DEVICE DTQ DATASCOPE CORP. 701051736

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK