BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 10066028 · Received May 18, 2020

    Report

    Report Number
    2249723-2020-00773
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 30, 2020
    Report Date
    July 30, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G4, G7, H2, H6(EVALUATION METHOD CODES), H10. GOOD FAITH EFFORTS (GFE) ATTEMPTS WERE MADE TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION ON THIS COMPLAINT EVENT. THE CUSTOMER REPORTED THAT THEY DON NOT HAVE ANY OTHER INFORMATION THAN WHAT IS ALREADY REPORTED IN B5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) STARTED ALARMING, "MAINTENANCE CODE #7". THE PATIENT HAD BEEN RECEIVED FROM THE CCL. THE CUSTOMER WAS GUIDED TO LOCATE A SECOND UNIT AND CALL THE GETINGE REPRESENTATIVE. THE IABP IN QUESTION WAS OPERATING PROPERLY AND PROVIDING PROPER THERAPY TO THE PATIENT. WHEN ANOTHER IABP WAS LOCATED, A CCL STAFFER TRANSITIONED THE PATIENT WITH MINIMAL DOWN TIME. NO PATIENT HARM, SERIOUS INJURY OR 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 AS PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. AT THIS TIME, THE CUSTOMER HAS NOT REQUESTED GETINGE TO EVALUATE THE IABP. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE CUSTOMER WITH REGARD TO THE REPAIR AND STATUS OF THE IABP, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) STARTED ALARMING, "MAINTENANCE CODE #7". THE PATIENT HAD BEEN RECEIVED FROM THE CCL. THE CUSTOMER WAS GUIDED TO LOCATE A SECOND UNIT AND CALL THE GETINGE REPRESENTATIVE. THE IABP IN QUESTION WAS OPERATING PROPERLY AND PROVIDING PROPER THERAPY TO THE PATIENT. WHEN ANOTHER IABP WAS LOCATED, A CCL STAFFER TRANSITIONED THE PATIENT WITH MINIMAL DOWN TIME. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528705 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1