BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4213130 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01110
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    November 18, 2011
    Report Date
    November 23, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM, BUT DID OBSERVE THE FAILURE CODE IN THE FAULT LOG. AS A PRECAUTIONARY MEASURE, THE COMPRESSOR/MOTOR ASSEMBLY (0102-00-0001), THE COMPRESSOR FAN ASSEMBLY (0119-00-0149), AND THE CLOSE ACTION THERMAL SWITCH (0263-00-0003) WERE 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 THE UNIT WAS IN USE ON A PATIENT DURING TRANSPORT, THE UNIT GENERATED A "MAINTENANCE REQUIRED CODE #4" (COMPRESSOR OVER-TEMPERATURE CONDITION). THE PATIENT WAS NOT WATCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455645 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1