BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 13019517 · Received December 16, 2021

    Report

    Report Number
    2249723-2021-02892
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 24, 2021
    Report Date
    June 22, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D5 (DEVICE AVAILABLE FOR EVAL), G4, G7, H2, H4, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: G1 (CONTACT PERSON).

    Additional Manufacturer Narrative · 0

    COMMUNICATION/INTERVIEWS: (4111/213) A (B)(4) FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER VIA A PHONE CALL. THE FSE ASSISTED THE STAFF WITH SECURING REPLACEMENT HELIUM TANK. THE ISSUE HAS BEEN RESOLVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A HELIUM LEAK. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916921 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown