BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 20088965 · Received August 28, 2024

    Report

    Report Number
    2249723-2024-03499
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 2, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER REPLACED THE FRONT PANEL, INCLUDING THE LABELS, AND CONDUCTED BOTH A FUNCTIONAL TEST AND A SAFETY CHECK. THE REPAIR HAS BEEN COMPLETED SUCCESSFULLY. UNIT CLEARED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0997-00-0644 ASSEMBLY, UPPER PANEL SERIAL NUMBER N/A PART NUMBER 0334-00-1811 LABEL, PATIENT CONNECTOR PART NUMBER 0334-00-1813 LABEL, TRAINER ON, OFF PART NUMBER 0997-00-0644 ASSEMBLY, UPPER PANEL SERIAL NUMBER N/A WAS RECEIVED WITH THE REPORTED FAILURE OF THE FIBER OPTIC DOOR STAYED OPEN. PART NUMBER 0334-00-1811 LABEL, PATIENT CONNECTOR AND PART NUMBER 0334-00-1813 LABEL, TRAINER ON, OFF HAVE NO RELATION TO THE FAILURE OF THE FIBER OPTIC DOOR. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION ON PART NUMBER 0997-00-0644 ASSEMBLY, UPPER PANEL AND VERIFIED THAT THE FIBER OPTIC DOOR REMAINED OPEN AND WOULD NOT SPRING BACK TO THE CLOSED POSITION. THE FAT DEPT. WAS ABLE TO REPLICATE THE FAILURE OF A DEFECTIVE FIBER OPTIC DOOR. THE UPPER PANEL FAILED TESTING. RETAINING THE UPPER PANEL IN THE FAT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THE FLAP ON THE FO CONNECTOR REMAINED OPEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179948 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown