BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CPB PACK

    MDR report key: 3983232 · Received July 3, 2014

    Report

    Report Number
    2248146-2014-00146
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND AN INVESTIGATION HAS BEEN INITIATED. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CUSTOM PERFUSION PACK HAD SMALL HOLES IN THE TOP OF THE PACK. NO PT WAS INVOLVED. RELATED TO MFR REPORT #: 2248146-2014-00147.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392359 ADULT CPB PACK CARDIOPULMONARY DEVICE DWF DATASCOPE CORP. BO-TOP 19100 16743-06

    Patients

    Seq Age Sex Outcome Treatment
    1