BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 9158579 · Received October 4, 2019

    Report

    Report Number
    2249723-2019-01600
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 4, 2019
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP. THE FSE DETERMINED THAT THE ISSUE WAS CAUSED DUE TO THE POWER SUPPLY. THE FSE VISITED THE CUSTOMER WITH A NEW POWER SUPPLY, HOWEVER THE FSE FOUND THAT THE NEW POWER SUPPLY WAS ALSO NOT WORKING WHICH WAS AN OUT OF BOX FAILURE. THIS OOB HAS BEEN REPORTED UNDER MFG REPORT NUMBER 2249723-2019-01597. SUBSEQUENTLY, THE FSE REPLACED THE POWER SUPPLY ONCE AGAIN WITH A NEW WORKING POWER SUPPLY AND PERFORMED ALL FUNCTIONAL AND SAFETY TESTS WHICH PASSED TO MEET FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE CHECK PERFORMED BY THE CUSTOMER, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT SWITCHING ON. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949722 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1