BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 8122009 · Received December 1, 2018

    Report

    Report Number
    2249723-2018-02091
    Event Type
    Malfunction
    Date Received
    December 1, 2018
    Date of Event
    November 6, 2018
    Report Date
    January 4, 2019
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN IDENTIFIED AS A DUPLICATE TO ANOTHER. PLEASE NOTE THAT ALL RELEVANT INFORMATION REGARDING THIS EVENT HAS BEEN CAPTURED AND SUBMITTED UNDER MFG REPORT # 2249723-2018-02067.

    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) FAILURES OF FIVE (5) DATASETTE DSS CS100. AS A RESULT OF THE OOB, THE SCREEN OF THE IABPS REMAINED BLACK AND NO FAILURE MESSAGE WAS DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT AND THIS IS AN OUT OF BOX FAILURE (OOB) EVENT. THIS RECORD HAS BEEN IDENTIFIED AS A DUPLICATE TO MFG REPORT # 2249723-2018-02067.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER THE COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. THE GETINGE FSE EVALUATED THE IABP UNITS AND REPLACED THE FAULTY DATASETTE DSS CS100 WITH A NEW ONES. AFTER REPLACEMENT OF THE DATASETTES, THE UNITS 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. (B)(6).

    Description of Event or Problem · 1

    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) FAILURES OF FIVE (5) DATASETTE DSS CS100. AS A RESULT OF THE OOB, THE SCREEN OF THE IABPS REMAINED BLACK AND 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
    962570 CS100 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1