BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE I (AU)

    MDR report key: 18764612 · Received February 22, 2024

    Report

    Report Number
    2249723-2024-00779
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    February 14, 2024
    Report Date
    December 26, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567109053
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFO FROM (B)(6) 2024 INDICATES GETINGE SERVICE ENGINEER DISCOVERED FAILURE DURING A RECALL (COILED CABLE) WAS DAMAGED/ ONE PIN WAS OUT, NO PATIENT WAS INVOLVED AND ADDITIONAL CUSTOMER INFO RECEIVED. JD (B)(6) 2024 ADDITIONAL INFORMATION: E1(EVENT SITE TELEPHONE:(B)(6) IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP). A GETINGE FIELD SERVICE ENGINEER (FSE) ATTENDED THE SITE AND LOCATED THE UNIT TO BE REPAIRED, DISMANTLED THE UNIT AND RE-FITTED NEW CABLE PNEU-MOD TO THE BACKPLANE BOARD.FSE REASSEMBLED THE UNIT AND PERFORMED ALL SAFETY CHECKS ON THE SYSTEM AS PER GETINGE SPECIFICATIONS. EXCESSIVE LEAK THROUGH THE SYSTEM WAS DETECTED/REOPEN THE UNIT TO INVESTIGATE, THE FAULT WAS RECTIFIED AND REASSEMBLED THE UNIT AND THE SYSTEM WAS RETURNED BACK TO SERVICE FULLY FUNCTIONAL. NOTE UNIT REQUIRE NEW SAFETY DISC SEE SPT TEST RESULTS FOR MORE DETAILS. SCROLL COMPRESSOR AND DRIVE REGULATORS REPLACED AS PER IVONS REQUEST SAFETY DISC REPLACED . COMPLETED FULL FUNCTIONAL CHECK OF DEVICE. ADJUSTED AND CHECKED DRIVE REGULATOR PRESSURES, ALL OK. RE-CALIBRATED 30 PSI PRESSURE TRANSDUCER. COMPRESSOR TEST COMPLETED - PASSED. HELIUM REGULATOR CHECK -PASSED. ALL MANIFOLDS TEST - PASSED. HELIUM LEAK TEST - PASSED. CHECKED DRIVE REGULATOR PRESSURES - ALL OK. ADJUSTED TIME AND DATE. EST COMPLETED. CHECKED AND EXTRACTED ERROR LOGS, ALL OK. BALLOON PUMP CLEARED FOR CLINICAL USE. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING UNRELATED SERVICING BY A GETINGE SERVICE ENGINEER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILED PPM; COILED CABLE WAS DAMAGED/ ONE PIN WAS OUT. NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237811 CARDIOSAVE HYBRID TYPE I (AU) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-31 10607567109053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown