BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3743603 · Received January 30, 2014

    Report

    Report Number
    2249723-2013-00219
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    November 24, 2013
    Report Date
    November 25, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP HAS BEEN REVIEWED. THERE ARE NO NONCONFORMANCES NOTED IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE OBSERVED THAT A "NO ZERO" MESSAGE OCCURS ON THE DISPLAY WHEN THE PRESSURE CABLE IS BENT WITH FORCE AT THE INPUT CONNECTION. HE REPLACED THE PRESSURE INPUT CABLE ASSEMBLY (PART NUMBER: 0012-00-0977). THE REPORT OF KEYS NOT FUNCTIONING WAS NOT DUPLICATED; HOWEVER, THIS MAY REFLECT THE CUSTOMER'S INABILITY TO ZERO THE PRESSURE CHANNEL. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, SOME OF THE KEYS OF THE IABP WERE NOT FUNCTIONING AND "NO ZERO" DISPLAYED AFTER INITIALLY ZEROING AND OBTAINING PRESSURE READINGS. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66490 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR