BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4004979 · Received July 23, 2014

    Report

    Report Number
    2249723-2014-00918
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CO REP WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. AS A PRECAUTIONARY MEASURE, THE CABLE ASSEMBLY BLOOD PRESSURE INPUT (012-00-0977) WAS REPLACED. THE UNIT WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE INSERTING THE BALLOON IN THE PATIENT, THE INVASIVE BLOOD PRESSURE WAVEFORM DID NOT APPEAR ON THE SCREEN. THE CUSTOMER TRIED A DIFFERENT CABLE BUT THE PROBLEM CONTINUED. THE CUSTOMER ADDED THAT WHEN THEY HELD PRESSURE ON THE CABLE THEY WERE ABLE TO GET A WAVEFORM TO APPEAR. THE PATIENT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429952 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1