BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 10419387 · Received August 18, 2020

    Report

    Report Number
    2249723-2020-01288
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 24, 2020
    Report Date
    February 26, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR'S GETINGE AUTHORIZED DISTRIBUTOR'S FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE, REPLACED THE MOTOR CONTROL BOARD. REPAIRS ARE STILL ON GOING. THE SUSPECTED FAULTY OOB MOTOR CONTROL BOARD WAS SENT TO GETINGE'S NATIONAL REPAIR CENTER (NRC) FOR EVALUATION. A SENIOR REPAIR TECHNICIAN INSPECTED THE MOTOR CONTROL BOARD AND NO VISUAL DAMAGE WAS OBSERVED. THE TECHNICIAN INSTALLED THE MOTOR CONTROL BOARD INTO CS100 TEST FIXTURE AND TESTED TO FACTORY SPECIFICATIONS PER C100 SERVICE MANUAL. THE MOTOR CONTROL BOARD PASSED TESTING. THE NRC COULD NOT VERIFY THE REPORTED FAILURE " ALARM ELECTRICAL FAILURE CODE 50, OOB FAILURE". THE MOTOR CONTROL BOARD IS BEING SENT TO THE SUPPLIER PER PROCEDURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE REPRESENTATIVE REPORTED THAT THE DISTRIBUTOR'S GETINGE AUTHORIZED DISTRIBUTOR'S FIELD SERVICE ENGINEER (FSE) REPLACED THE MOTOR CONTROL BOARD TO FIX THE ISSUE. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. ADDITIONALLY, THE SUPPLIER HAD RETURNED THE SUSPECTED FAULTY OOB MOTOR CONTROL BOARD BACK TO THE NATIONAL REPAIR CENTER (NRC). THE SUPPLIER REPORTED THAT THEY COULD NOT VERIFY THE REPORTED FAILURE. THE MOTOR CONTROL BOARD PASSED ALL OF THEIR TESTING. THE SENIOR REPAIR TECHNICIAN OF THE NRC INSTALLED MOTOR CONTROL BOARD INTO THE CS100 TEST FIXTURE AND TESTED TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL AND PASSED TESTING. THE NRC COULD NOT VERIFY THE REPORTED FAILURE " ALARM ELECTRICAL FAILURE CODE 50. OOB FAILURE". THE MOTOR CONTROL BOARD WAS SCRAPPED AND RETAINED IN THE NRC PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO BEING INSTALLED IN THE HOSPITAL, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ALARM AND CODE 50. THIS WAS AN OUT-OF-BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO BEING INSTALLED IN THE HOSPITAL, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ALARM AND CODE 50. THIS WAS AN OUT-OF-BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO BEING INSTALLED IN THE HOSPITAL, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ALARM AND CODE 50. THIS WAS AN OUT-OF-BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS PROVIDED TO US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO BEING INSTALLED IN THE HOSPITAL, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) HAD AN ALARM AND CODE 50. THIS WAS AN OUT-OF-BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883465 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1