BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON PUMP

    MDR report key: 35334 · Received July 12, 1996

    Report

    Report Number
    35334
    Event Type
    Injury
    Date Received
    July 12, 1996
    Date of Event
    March 7, 1996
    Report Date
    March 15, 1996
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AUTO FILL FAILURE, PUMP QUIT ON PT. CALLED CO TO CHECK. CO FOUND BROKEN IMPELLOR ON KNF MOTOR ASSY. CAUSED MOTOR TO OVERHEAT. CO'S SVC FOUND MOTOR FAN INTERNAL BROKEN OFF SHAFT CAUSING MOTOR TO OVERHEAT AND SHUT DOWN. TESTED UNIT OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON PUMP BALLOON PUMP DSP DATASCOPE CORP. SYSTEM 90 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening