BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 18868803 · Received March 8, 2024

    Report

    Report Number
    2249723-2024-00980
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 5, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D8, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11. CORRECTED FIELDS- E1(EVENT SITE ADDRESS AND EVENT SITE CITY). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED INTERNAL COMMUNICATION ERROR 124 OCCURRED DURING PRE-DELIVERY INSPECTION. SOLENOID CONTROL BOARD AND DRIVE MANIFOLD REPLACED. REGULAR CALIBRATION AND REGULAR INSPECTION BASED ON THE REGULAR INSPECTION RECORD SHEET WERE PERFORMED. THE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF COMMUNICATION ERROR OCCURRED. PERFORMED VISUAL INSPECTION OF THESE PARTS RECEIVED AND ALL PARTS LOOKS TO BE IN CONDITION. INSTALLED BOTH PARTS INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TOGETHER AND SEPARATELY TO THE FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF COMMUNICATION ERROR OCCURRED. ALSO, THE FAT DEPT. PUMPED THE CARDIOSAVE TEST FIXTURE WITH BOTH PARTS AND DID NOT OBSERVE COMMUNICATION ERROR MESSAGE ON SCREEN. BOTH PARTS PASSED TESTING. THE FAT DEPT RECEIVED PARTS FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING- 1. PERFORM VISUAL CHECK, RESULT: NO ABNORMALITIES FOUND. 2. BOARD WAS RE-TESTED AT FCT, RESULT: PASSED. RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE DELIVERY INSPECTION BY A GETINGE FIELD SERVICE ENGINEER (GFSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A COMMUNICATION ERROR, THIS OCCURRED IMMEDIATELY AFTER TURNING ON THE MAIN POWER AND STARTING TO PUMP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944546 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown