BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4213095 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01122
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    December 5, 2011
    Report Date
    December 5, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THAT THE UNIT DISPLAYED A VERY INTERMITTENT ERRATIC INVASIVE BLOOD PRESSURE WITH THE SIMULATOR HOOKED UP. THE COMPANY REP REPLACED THE FRONT END BOARD (B)(4) AND INTERNAL PRESSURE CABLE (B)(4). THE UNIT WAS TESTED TO FACTORY SPEC. IT FUNCTIONAL NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE INVASIVE BLOOD PRESSURE DISPLAYED ON THE UNIT WOULD FLATLINE AND NOT CHANGE SCALE AUTOMATICALLY. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455617 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1