BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3950689 · Received June 6, 2014

    Report

    Report Number
    2249723-2014-00792
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    January 1, 2013
    Report Date
    November 4, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SVC REP EVALUATED THE UNIT AND WAS UNABLE TO DUPLICATE THE EVENT. THE UNIT WAS FOUND FUNCTIONING, HOWEVER, IT WAS TESTED FOR ON (1) MONTH AND THE ISSUE RECURRED. THE COMP REP REPLACED THE COILED CABLE ASSEMBLY (PART #:0012-00-1422). IN AN UNRELATED REPAIR THE HELIUM TANK VALVE KNOB (PART #:0366-00-0092) WAS ALSO REPLACED. PERFORMED FUNCTIONAL TESTS AND SAFETY CHECKS TO FACTORY SPECIFICATIONS. THE UNIT WAS RELEASED TO THE CUSTOMER. THE COILED CABLE ASSEMBLY REPLACED WAS RECEIVED BY THE MANUFACTURING FACILITY AT (B)(4) AND IS ON EVAL. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE DISPLAY WAS JITTERING. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331605 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100

    Patients

    Seq Age Sex Outcome Treatment
    1