BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 7940348 · Received October 5, 2018

    Report

    Report Number
    2249723-2018-01721
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    May 10, 2018
    Report Date
    January 3, 2019
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATASETTE DSS WAS RETURNED TO THE GETINGE NATIONAL REPAIR CENTER (NRC) FROM THE SUPPLIER. THE SUPPLIER WAS ABLE TO VERIFY THE REPORTED FAILURE. THEY STATED THAT U1 IS UN-PROGRAMMABLE. THE DATASETTE WAS SCRAPPED AND RETAINED IN THE NRC PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FIELD ACTION PERFORMED BY A GETINGE AUTHORIZED DISTRIBUTOR, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) FAILED TO POWER UP WHEN THE NEW DATASETTES WERE INTRODUCED. THE DISTRIBUTOR ATTEMPTED TO REPLACE WITH A 2ND SET OF DATASETTES AND DISCOVERED THAT THE PART MALFUNCTIONED AS AN OUT OF BOX (OOB) FAILURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED. THE 1ST SET OF DATASETTES THAT FAILED (OOB) WAS REPORTED UNDER MFG REPORT# 2249723-2018-01619.

    Additional Manufacturer Narrative · 1

    THE FAULTY DATASETTE DSS WAS RETURNED TO THE GETINGE NATIONAL REPAIR CENTER (NRC) FOR FURTHER EVALUATION OF THE OUT OF BOX (OOB) FAILURE. A SENIOR REPAIR TECHNICIAN OF THE NRC INSPECTED THE DATASETTE DSS AND NO VISUAL DAMAGE WAS OBSERVED. THE TECHNICIAN INSTALLED THE DATASETTE DSS INTO THE MAIN BOARD OF A CS100 TEST FIXTURE AND TESTED TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL. THE PART FAILED TESTING AND THE REPORTED FAILURE "PUMP FAILED TO POWER UP" WAS VERIFIED. THE DATASETTE WILL BE SENT TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) IS NOT REQUIRED TO BE REVIEWED PER GETINGE STANDARD OPERATING PROCEDURE SINCE THE IABP WAS MANUFACTURED MORE THAN A YEAR BEFORE THE DATE OF EVENT. THE GETINGE AUTHORIZED DISTRIBUTOR WHO FOUND THE ISSUE INSTALLED ANOTHER SET OF DATASETTES AND THE IABP STARTED UP. FULL EVENT SITE NAME: (B)(6). FULL NAME OF INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FIELD ACTION PERFORMED BY A GETINGE AUTHORIZED DISTRIBUTOR, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) FAILED TO POWER UP WHEN THE NEW DATASETTES WERE INTRODUCED. THE DISTRIBUTOR ATTEMPTED TO REPLACE WITH A 2ND SET OF DATASETTES AND DISCOVERED THAT THE PART MALFUNCTIONED AS AN OUT OF BOX (OOB) FAILURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED. THE 1ST SET OF DATASETTES THAT FAILED (OOB) WAS REPORTED UNDER MFG REPORT# 2249723-2018-01619.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FIELD ACTION PERFORMED BY A GETINGE AUTHORIZED DISTRIBUTOR, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) FAILED TO POWER UP WHEN THE NEW DATASETTES WERE INTRODUCED. THE DISTRIBUTOR ATTEMPTED TO REPLACE WITH A 2ND SET OF DATASETTES AND DISCOVERED THAT THE PART MALFUNCTIONED AS AN OUT OF BOX (OOB) FAILURE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED. THE 1ST SET OF DATASETTES THAT FAILED (OOB) WAS REPORTED UNDER MFG REPORT# 2249723-2018-01619.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778218 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1