BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 8117385 · Received November 29, 2018

    Report

    Report Number
    2249723-2018-02067
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 4, 2019
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TECHNICIAN OF THE GETINGE NATIONAL REPAIR CENTER (NRC) REPORTED THAT THE SUPPLIER STATED VIA EMAIL THAT THEY REPROGRAMMED THE THREE (3) IAB DATASETTES. IN ADDITION, THE SUPPLIER STATED THAT U1 WAS NOT PROGRAMMABLE, SCRAPPED THE THREE (3) DSS DATASETTES AND REPROGRAMMED THE REMAINING TWO (2) DSS DATASETTES. THE NRC DID NOT RECEIVE ANY OF THE IAB DATASETTES OR DSS DATASETTES BACK FROM THE SUPPLIER FOLLOWING THEIR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE GETINGE FSE EVALUATED THE IABP UNITS AND REPLACED THE FAULTY DATASETTES WITH NEW ONES. AFTER REPLACEMENT OF THE DATASETTES, THE UNITS WERE RECHECKED AND ALL TESTING PASSED. THE FSCA WAS COMPLETED AND THE IABPS WERE RETURNED TO THE CUSTOMER FOR CLINICAL USE. THE DEFECTIVE PARTS WILL BE RETURNED TO GETINGE FOR MANUFACTURER'S EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PART EVALUATION. DATASETTES IAB & DSS WERE RECEIVED AT THE GETINGE NATIONAL REPAIR CENTER (NRC). A SENIOR REPAIR TECHNICIAN OF THE NRC INSPECTED THREE (3) DATASETTES IAB AND NO VISUAL DAMAGE WAS OBSERVED. FIVE (5) DATASETTES DSS WERE INSPECTED AND NO VISUAL DAMAGE WAS OBSERVED. THE TECHNICIAN OF THE NRC INSTALLED THE DATASETTES IAB INTO THE BOARD OF CS100 TEST FIXTURE AND TESTED TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL. TESTING PASSED AND THE TECHNICIAN COULD NOT VERIFY THE REPORTED FAILURE OF ¿BLACK SCREEN AND NO FAILURE MESSAGE¿. THE DATASETTES WERE SENT TO THE SUPPLIER PER PROCEDURE. THE TECHNICIAN OF THE NRC INSTALLED THE DATASETTES DSS INTO THE BOARD OF CS100 TEST FIXTURE AND TESTED TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL. THREE (3) OF THE DATASETTES FAILED TESTING WITH A BLANK SCREEN AND AN AUDIO ALARM. THE DATASETTES WERE SENT TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE. TWO (2) OF THE DATASETTES PASSED TESTING TO FACTORY SPECIFICATIONS PER CS100 SERVICE MANUAL AND WERE SENT TO THE SUPPLIER PER PROCEDURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS MADE AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PERFORMING THE DATASETTE FIELD SERVICE CORRECTIVE ACTION (FSCA) ON THE CS100 INTRA-AORTIC BALLOON PUMPS (IABP), THE GETINGE FIELD SERVICE ENGINEER (FSE) DISCOVERED AN OUT OF BOX (OOB) FAILURE OF EIGHT (8) DATASETTES. AS A RESULT OF THE OOB FAILURE, THE SCREEN OF THE IABPS REMAINED BLACK AND NO FAILURE MESSAGE WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PERFORMING THE DATASETTE FIELD SERVICE CORRECTIVE ACTION (FSCA) ON THE CS100 INTRA-AORTIC BALLOON PUMPS (IABP), THE GETINGE FIELD SERVICE ENGINEER (FSE) DISCOVERED AN OUT OF BOX (OOB) FAILURE OF EIGHT (8) DATASETTES. AS A RESULT OF THE OOB FAILURE, THE SCREEN OF THE IABPS REMAINED BLACK AND NO FAILURE MESSAGE WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    PRODUCTION DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED AS THIS COMPLAINT IS FOR AN OUT-OF-BOX PART FAILURE. THE GETINGE FSE EVALUATED THE IABP UNIT AND REPLACED THE FAULTY DATASETTE WITH A NEW ONE. AFTER REPLACEMENT OF THE DATASETTE, THE UNIT WAS RECHECKED AND ALL TESTING PASSED. THE FSCA WAS COMPLETED AND THE IABP WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. HOWEVER, THE DEFECTIVE PART WILL BE RETURNED TO GETINGE FOR MANUFACTURER'S EVALUATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PART EVALUATION. THE FULL NAME OF THE INITIAL REPORTER LISTED IS (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER REPLACEMENT OF THE DATASETTE UNDER THE CURRENT DATASETTE FIELD SERVICE CORRECTIVE ACTION (FSCA) BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE SCREEN OF THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) REMAINED BLACK, BUT NO FAILURE MESSAGE WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT AND THIS IS AN OUT OF BOX FAILURE (OOB) EVENT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957691 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1