BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3902628 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00539
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THAT THE SCREEN AND THE KEYBOARD DID NOT LIGHT UP AND THE IABP DID NOT INITIALIZE THE BOOT PROCESS. HE CHECKED ALL CONNECTIONS. THE COMPANY REP REPLACED THE POWER SUPPLY (PART NUMBER 0014-00-0033E05) TO TROUBLESHOOT THE PROBLEM RESULTING IN THE UNIT BOOTING UP. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. INTERNAL FILE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE UNIT DID NOT INITIALIZE THE BOOT UP PROCESS OR POWER ON. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282299 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1