BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 17105706 · Received June 12, 2023

    Report

    Report Number
    2249723-2023-02722
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 30, 2023
    Report Date
    January 16, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED THE SAFETY DISK. THE FSE PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0202-00-0140 REV J. SN: (B)(6), SAFETY DISK WITH A REPORTED UNIT FAILURE OF A FAILED PIM TEST. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. TESTED PN: 0202-00-0140 IN CARDIOSAVE TEST FIXTURE TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. PERFORMED THE ALL MANIFOLD TEST FOR 20 MINUTES AND IT WAS FOUND THAT THE SAFETY DISK FAILED THE LEAK PORTION OF THE PIM TEST. FAT WAS ABLE TO REPLICATE AND VERIFY THE REPORTED ISSUE OF THE FAILED PIM TEST. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPT. PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE DELIVERY TEST, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED DURING SAFETY DISK CHECK. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275648 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown