BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3416758 · Received September 30, 2013

    Report

    Report Number
    2249723-2013-00108
    Event Type
    Malfunction
    Date Received
    September 30, 2013
    Date of Event
    August 9, 2013
    Report Date
    August 9, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THAT THE POWER CORD WAS BURNED AT THE CONNECTOR WHERE IT WAS PLUGGED INTO THE WALL RECEPTACLE. HE OBSERVED THAT THE ISSUE WAS WITH THE WALL RECEPTACLE, NOT THE POWER CORD. THE COMPANY REPRESENTATIVE REPLACED THE POWER CORD (PART NUMBER 0012-00-0886-01). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, THE PLUG ON THE POWER CORD OF THE IABP STARTED TO SMOKE AFTER IT WAS PLUGGED INTO A WALL OUTLET. WHEN THE CUSTOMER UNPLUGGED THE IABP, ONE OF THE THREE PRONGS ON THE PLUG BROKE OFF IN THE WALL OUTLET. THE IABP WAS REPLACED AND THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493637 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI