BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4077300 · Received August 22, 2014

    Report

    Report Number
    2249723-2014-01231
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    November 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CO REP OBSERVED NO SOLENOID VOLTAGE TO SOLENOID. THE CO REP REPLACED THE MAIN/SOLENOID DRIVER JP1 CABLE (PART NUMBER: 0012-00-1096-01). THE IABP 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 PRIOR TO USE ON A PATIENT, THE IABP GENERATED A "LOW VACUUM" ALARM. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508391 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1