BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21033911 · Received December 30, 2024

    Report

    Report Number
    2249723-2024-0005328
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 11, 2024
    Report Date
    March 12, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, D5, E1 (INITIAL REPORTER, EVENT SITE MAIL), E2, E3, E4, G1, G2, G3, G6, H2, H6 (HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODES, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENET CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED PANEL ASSEMBLY OPTIC FIBER COVER (0997-00-0644). AS PRECAUTIONARY SERVICE REPLACED LABEL, PATIENT CONNECTOR, LABEL, TRAINER ON ¿ OFF. DOPPLER ASSEMBLY BACK-BATTERY COVER MALFUNCTIONING/MISSING A QUOTE WILL BE PROVIDED UPON REQUEST. RAN ALL THE TESTS IN ACCORDANCE TO THE MANUFACTURER'S SPECIFICATIONS. UNIT CLEARED FOR USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0644 WITH A REPORTED UNIT FAILURE OF A FAULTY FIBER OPTIC COVER. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO HAVE A FAULTY FIBER OPTIC DOOR COVER. CONFIRMED THE REPORTED ISSUE. PROBABLE ROOT CAUSE IS EXPECTED WEAR AND TEAR. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AS.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME, EVENT SITE (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE PERFORMED BY THE GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD ISSUES WITH UPPER PANEL ASSEMBLY AND FIBER OPTIC COVER. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD ISSUES WITH UPPER PANEL ASSEMBLY AND FIBER OPTIC COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2449152 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown