BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4046999 · Received August 26, 2014

    Report

    Report Number
    2249723-2014-01195
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    September 8, 2012
    Report Date
    September 8, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE DISCONNECTED THE OPTICAL SENSOR CABLE CONNECTOR, CLEANED AND RECONNECTED IT. HOWEVER, THE CALIBRATION OF THE OPTICAL SENSOR WAS NOT ACHIEVED AND THE ALARM "UNABLE TO CALIBRATE IAB OPTICAL SENSOR" PERSISTED. THE IABP WAS EVALUATED AND THE EVENT WAS NOT DUPLICATED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE SECOND IABP WAS IN USE ON A PT, AN ALARM "UNABLE TO CALIBRATE IAB OPTICAL SENSOR" WAS DISPLAYED. THIS IABP WAS REPLACED AFTER UNSUCCESSFUL TROUBLE SHOOTING OF THE FIRST IABP, WHICH DISPLAYED SAME ALARM. REFER TO MDR 2249723-2014-01194 (INTERNAL) COMPLAINT # P-12-00383) FOR THE FIRST IABP. FOR THIS IABP, THE MODE WAS SHIFTED FROM AUTOMATIC TO THE SEMI-AUTOMATIC MODE WITH ECG AND THE PRESSURE WAS MONITORED BY ANOTHER WAY. THE CUSTOMER COMPLETED THE IAB THERAPY WITHOUT PROBLEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518384 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1