BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4096304 · Received August 20, 2014

    Report

    Report Number
    2249723-2014-00984
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    June 26, 2012
    Report Date
    June 26, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLACED THE DRIVE MANIFOLD ASSEMBLY (P/N: 0104-00-0018) AND PERFORMED THE FULL FUNCTIONAL AND SAFETY CHECKS ON THE IABP. THE IABP MET THE FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. NOTE: REFER TO MDR 2249723-2014-00 (INTERNAL COMPLAINT# P-12-00557) FOR THE FIRST OCCURRENCE ON THE SAME IABP. (B)(4).

    Description of Event or Problem · 1

    DURING THE SERVICE PERFORMED BY THE CUSTOMER, THE IABP GENERATED A K6, K6A, K7 AND K8 "LEAK TEST FAILURE #3" (+/-20MM HG). NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501029 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1