BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 6756356 · Received August 1, 2017

    Report

    Report Number
    2249723-2017-00183
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    July 6, 2017
    Report Date
    July 31, 2017
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER THE COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. THE SERVICE TERRITORY MANAGER (STM) REPORTED THAT HE WAS UNABLE TO DUPLICATE THE ALLEGED MALFUNCTION. BUT THE FACILITY'S CLINICAL ENGINEER DID REPORT SEEING THE IABP MALFUNCTION. SO AS A PRECAUTION THE STM REPLACED THE POWER SUPPLY. WHEN THE STM ARRIVED THE LOG FILES HAD ALREADY BEEN CLEARED. THE IABP PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, CLEARED FOR CLINICAL USE AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN INTERMITTENT POWER PROBLEM WHEN SWITCHING FROM AC POWER TO BATTERY AND VICE VERSA. NO PATIENT INVOLVEMENT. EVENT DISCOVERED DURING DAILY CHECKS BEFORE USE ON PATIENT. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539188 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1