BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4213102 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01118
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    November 17, 2011
    Report Date
    November 21, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE PRESSURE TRANSDUCER (PART NUMBER 0682-00-0076-01). THE UNIT WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED AN ELECTRICAL TEST FAIL CODE #53 (SHUTTLE TRANSDUCER OFFSET FAILURE) ALARM AND HIGH PRESSURE ALARM. THE IABP WAS STOPPED AND BALLOON CATHETER WAS REMOVED. THE IABP WAS RESET, SELF-TEST WAS 'OK'; THE THERAPY WAS CONTINUED. HOWEVER, AFTER SEVERAL HOURS, THE IABP GENERATED AN ELECTRICAL TEST FAIL CODE #53 (SHUTTLE TRANSDUCER OFFSET FAILURE) ALARM AGAIN. THE IABP WAS REPLACED AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455649 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1