BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19906674 · Received August 5, 2024

    Report

    Report Number
    2249723-2024-03154
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 16, 2024
    Report Date
    February 20, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H6, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, COMPONENT CODE. FSE REPLACED THE DAMAGED PARTS (BEZEL, UPPER DISPLAY (D380-00-0559), BEZEL, LOWER DISPLAY (D380-00-0560), SEAL, DISPLAY .059 X .100 X 7.45 (D354-00-0210-03), SEAL, DISPLAY .059 X .100 X 10.07 (D354-00-0210-04), ASSEMBLY,UPPER PANEL (D997-00-0644), DISPLAY TOP COVER ASSY WITH TAPE KIT (D040-00-0457), DISPLAY, FILLER STRAIN RELIEF (D380-00-0619). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO THE CUSTOMER AND RELEASED FOR CLINICAL USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) (B)(6). THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT WITH A REPORTED UNIT FAILURE OF SEVERAL CRACKED PIECES AND A BROKEN FIBER OPTIC DOOR ON THE UPPER PANEL. PERFORMED A VISUAL INSPECTION AS WELL. PN: 0380-00-0559 - CRACK, PN: 0380-00-0560 - CRACK, PN: 0997-00-0644 - FAULTY FIBER OPTIC DOOR. PN 0040-00-0457- THIN CRACK. CONFIRMED THE REPORTED FAILURES. PROBABLE ROOT CAUSE IS EITHER USER ERROR OR EXPECTED WEAR AND TEAR. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER: (B)(4). THE PROBABLE ROOT CAUSE IS EXPECTED WEAR AND TEAR.

    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

    N/A

    Description of Event or Problem · 0

    T WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A CRACKED UPPER LCD COVER AND BROKEN FIBER DOOR. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843854 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 N/A.