BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING PACK

    MDR report key: 4210830 · Received August 1, 2014

    Report

    Report Number
    2248146-2014-00293
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 1, 2012
    Report Date
    June 6, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    TUBING PACT BEQ-TOP-8800 WAS PUT ON A PATIENT AT 2:30 AM, ON (B)(6) 2012. THE OXYGENATOR CLOTTED OFF AND NEEDED TO BE CHANGED ON (B)(6) 2012. THE PATIENT WAS POLYCYTHEMIC BUT CLINICIAN WANTS OXYGENATOR CHECKED. TWO RETURN KITS WERE SENT FOR THE RETURN OF THE KIT ON (B)(6) 2012. TO DATE NO DEVICE HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451938 TUBING PACK CARDIOPULMONARY DEVICE DWF DATASCOPE CORP. BEQ-TOP 8800

    Patients

    Seq Age Sex Outcome Treatment
    1