BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4063320 · Received August 8, 2014

    Report

    Report Number
    2249723-2014-01159
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 2, 2012
    Report Date
    July 3, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ADVISED BY TECH SUPPORT TO CHECK THE ECG SIGNAL CABLE FOR SIGNS OF DAMAGE, OR A LOOSE CONNECTION, AND REPLACED THE SIGNAL CABLE IF THE NOISY SIGNAL WAS NOT CORRECTED. THE UNIT DISPLAYED A NOISY ECG SIGNAL WHILE USING A TRAINER WHICH ELIMINATES THE PATIENT LEADS AND CABLES AS A POSSIBLE SOURCE OF NOISY SIGNAL. THE CUSTOMER WAS ADVISED TO REPLACE ECG SIGNAL CABLE P/N 0012-00-0976. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE SYSTEM WAS IN USE ON A PATIENT, THE ECG SIGNAL BECAME NOISY SHOWING A LARGE NUMBER OF ARTIFACTS. THE SYSTEM WAS RUNNING IN AUTO OPERATION AND AUTOMATICALLY SWITCHED TO PRESSURE AS THE TRIGGER SOURCE. ALTHOUGH THE UNIT WAS STILL ASSISTING CORRECTLY, IT WAS SWITCHED OUT WITH ANOTHER PUMP, AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473126 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1