BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE CORPORATION

    MDR report key: 244406 · Received October 8, 1999

    Report

    Report Number
    244406
    Event Type
    Malfunction
    Date Received
    October 8, 1999
    Date of Event
    September 23, 1999
    Report Date
    October 7, 1999
    Manufacturer
    DATA SCOPE CORP. CARDIAC ASSIST DIV.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BLACK "ON/OFF" SWITCH THAT IS LOCATED RIGHT ABOVE THE GRAY PLUG WAS TURNED OFF. THIS DID NOT ALLOW THE BATTERY TO CHARGE. ATTEMPTS AT PLUGGING THE EQUIPMENT IN WAS NOT HELPFUL AS THE SWTICH CONTROLLED ENERGY SOURCE TO BATTERY ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE CORPORATION INTRA AORTIC BALLOON PUMP DSP DATA SCOPE CORP. CARDIAC ASSIST DIV. SYSTEM 98 0998-00-0446-53 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR