BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16268433 · Received January 30, 2023

    Report

    Report Number
    2249723-2023-00777
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    May 13, 2021
    Report Date
    March 13, 2023
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: B5, H4, H6(INVESTIGATION FINDINGS, COMPONENT CODES & INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT DISCOVERED THE ISSUE RESOLVED THE ISSUE BY REPLACING THE MISSING PAN HEAD SCREW (0212-12-0405). THE FSE CONTINUED WITH SET UP AND INSTALLATION OF THE UNIT. UNIT PASSED ALL REQUIREMENTS FOR INSTALLATION PER SERVICE MANUAL. UNIT IS CLEARED FOR CLINICAL USE AND RELEASED TO CUSTOMER. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSTALLATION AND WHILE SERVICING A UNIT PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCREW MISSING. THERE WAS NO PATIENT INVOLVEMENT. RELATED (B)(4) - (AUTOFILL FAILURE). RELATED (ORIGINAL) (B)(4) (SHIPPING RELATED ISSUE - DISPLAY FAILURE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSTALLATION AND UNIT SERVICING, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN AUTOFILL FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775158 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose N/A.