BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19510720 · Received June 11, 2024

    Report

    Report Number
    2249723-2024-02479
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 21, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9(DEVICE AVAILABLE FOR EVAL), G3, G6, H2, H3, H4, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS, COMPONENT CODES & INVESTIGATION CONCLUSIONS), H11 CORRECTED FIELDS: D4(UDI#). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND THE GROUNDING PLUG ON THE POWER CORD WAS BROKEN ALONG WITH THE DOOR ON THE FIBER OPTIC PORT. FSE REPLACED THE UPPER PANEL ASSEMBLY (D997-00-0644) AND POWER CORD REEL (D012-00-1688-21) TO RESOLVE THE ISSUE. FSE PERFORMED A PM, FULL CALIBRATION, AND TESTED THE UNIT. THE PRODUCT PASSED ALL FUNCTIONAL/SAFETY TESTING. RETURNED THE UNIT TO THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN POWER CORD. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171550 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 NA Unknown