BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 18414101 · Received December 28, 2023

    Report

    Report Number
    2249723-2023-05526
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 20, 2023
    Report Date
    January 17, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS BEING DISPATCHED IN ORDER TO EVALUATE THE UNIT AND DURING THE PERIOD OF AN EVALUATION FSE HAD FURTHER CHECKED THE LOGS AND IT WAS SHOWING THAT THE "IABP MAY REQUIRE MAINTENANCE" DURING INITIAL START UP. AFTER THAT THE FSE HAD FURTHER REPLACED THE "D670-00-1167"- PCB,PNEUMATICS INTERFACE, ROHS SO, THAT AFTER THE REPLACEMENT THE UNIT HAD PASSED ALL THE FUNCTIONAL TESTS AND SAFETY TESTS ACCORDING TO THE FACTORY SPECIFICATIONS. THE MACHINE WAS RETURNED TO CUSTOMER AND CLEARED FOR THE CLINICAL USE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART WITH A REPORTED UNIT FAILURE OF AN IABP REQUIRES MAINTENANCE MESSAGE. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO ISSUE CONFIRMED. SENDING THE BOARD TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY SAPAN RANA, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE. THE FAT DEPT. RECEIVED PART, PCBA, PNEUMATICS INTERFACE FROM THE SUPPLIER. SUPPLIER INVESTIGATION: PERFORMED VISUAL CHECK AND NO ABNORMALITY FOUND. BOARD WAS RE-TESTED AT FCT AND PASSED. RESULT AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. RETAINING THIS BOARD IN THE FAT DEPT. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS BEING DISPATCHED IN ORDER TO EVALUATE THE UNIT AND DURING THE PERIOD OF AN EVALUATION FSE HAD FURTHER CHECKED THE LOGS AND IT WAS SHOWING THAT THE "IABP MAY REQUIRE MAINTENANCE" DURING INITIAL START UP. AFTER THAT THE FSE HAD FURTHER REPLACED THE "D670-00-1167"- PCB, PNEUMATICS INTERFACE, ROHS SO, THAT AFTER THE REPLACEMENT THE UNIT HAD PASSED ALL THE FUNCTIONAL TESTS AND SAFETY TESTS ACCORDING TO THE FACTORY SPECIFICATIONS. THE MACHINE WAS RETURNED TO CUSTOMER AND CLEARED FOR THE CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS INTERNAL COMMUNICATION FAILURE. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530414 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown