BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 9125172 · Received September 26, 2019

    Report

    Report Number
    2249723-2019-01549
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    April 10, 2018
    Report Date
    February 3, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G4, G7,H2, H10. THE SUPPLIER VERIFIED THE REPORTED FAILURE. THEY STATED U1 WAS DEFECTIVE AND UNABLE TO REPROGRAM. THE SUPPLIER SCRAPPED DSS DATASETTE P/N 0670-00-1185 S/N (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FIELD SERVICE CORRECTIVE ACTION (FSCA) RECALL RELATED TO A SOFTWARE UPDATE THAT WAS PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE NEW DATASETTE FOR THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) FAILED TO WORK WHEN INSTALLED. THIS IS AN OUT OF BOX (OOB) FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    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. THE GETINGE SERVICE TERRITORY MANAGER (STM) THAT ENCOUNTERED THE ISSUE, REPLACED THE OOB DATASETTE WITH ANOTHER NEW DATASETTE, AND THEN PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THE SUSPECTED FAULTY OOB DATASETTE WAS SENT TO GETINGE'S NATIONAL REPAIR CENTER (NRC) FOR EVALUATION. A SENIOR REPAIR TECHNICIAN INSPECTED THE DATASETTE AND NO VISUAL DAMAGE WAS OBSERVED. THE TECHNICIAN THEN INSTALLED THE DATASETTE INTO CS100 TEST FIXTURE AND IT TESTED TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL AND IT FAILED TESTING. THE TECHNICIAN VERIFIED THE REPORTED FAILURE OF NO POWER UP OR DISPLAY. THE DATASETTE IS BEING SENT TO THE SUPPLIER FOR FAILURE ANALYSIS AS PER PROCEDURE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FIELD SERVICE CORRECTIVE ACTION (FSCA) RECALL RELATED TO A SOFTWARE UPDATE THAT WAS PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE NEW DATASETTE FOR THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) FAILED TO WORK WHEN INSTALLED. THIS IS AN OUT OF BOX (OOB) FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916567 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1