BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPULMONARY DEVICE

    MDR report key: 3874573 · Received April 22, 2014

    Report

    Report Number
    2248146-2014-00059
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, THEREFORE AN EVALUATION CANNOT BE PERFORMED TO DETERMINE ROOT CAUSE OF THE REPORTED EVENT. DEVICE LOT INFORMATION WAS ALSO NOT PROVIDED SO A REVIEW OF HISTORY RECORDS COULD NOT BE PERFORMED. IF THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RACEWAY TUBING CONTAINED IN THE TUBING PACK IS DISCOLORED AND DISCONFIGURED IN THE RACEWAY OVAL. NO PATIENT USE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243210 CARDIOPULMONARY DEVICE DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1