BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

    MDR report key: 18164125 · Received November 17, 2023

    Report

    Report Number
    2249723-2023-04942
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    November 10, 2023
    Report Date
    April 25, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 UNIT AND REPLACED CABLE (D012-00-1830-01) AND PERFORMED FUNCTIONAL CHECKS. REPAIR HAS BEEN COMPLETED. THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. RECEIVED CABLE, PART NUMBER 0012-00-1830-01 WITH A REPORTED UNIT FAILURE OF NO AUGMENTATION. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PART ON THE CARDIOSAVE TRAINER AND CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. IT WAS FOUND THAT THE CABLE WAS DEFECTIVE AND NO COMMUNICATION BETWEEN THE TRAINER AND THE TEST FIXTURE WAS POSSIBLE. THIS LEAD TO THE NO AUGMENTATION FAULT THAT WAS REPORTED. FAT WAS ABLE TO REPLICATE THE REPORTED FAILURE BUT NO ROOT CAUSE WAS DEFINED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD NO AUGMENTATION . THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674158 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.