BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17646509 · Received August 29, 2023

    Report

    Report Number
    2249723-2023-03828
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 18, 2023
    Report Date
    May 23, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER (FSE) CAN REPRODUCE THE REPORTED FAILURE AND STATED ALL TESTS WERE CONDUCTED AND THE SAFETY DISCREPANCY DID NOT PASS. FSE REPLACED THE SAFETY DISC, SCREW KIT, BACKUP ALARM BATTERY, TIDAL DISK, SCROLL COMPRESSOR, 100 MICRON FILTER, 1/8 FILTER (SAFETY DISK, DRIVE SIDE, TIDAL VOLUME DISK, COMPRESSOR SCROLL, MUFFLER MICRON , EXEC PROCESSOR BOARD, TOUCHSCREEN, O-RING. CALIBRATION BASED ON SERVICE MANUAL, SYSTEM FUNCTION TEST IMPLEMENTATION TEST AND SAFETY.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, E1(SEVENT SITE POSTAL CODE - 0030027, EVENT SITE STATE - 01), E2, E3, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDING, INVESTIGATION CONCLUSIONS), H10, H11. A GETINGE FIELD SERVICE ENGINEER (FSE) CAN REPRODUCE THE REPORTED FAILURE AND STATED WILL RETURN IT AFTER REPLACING 12 PARTS. THE SERVICE DETAILS ARE NOT PROVIDED. NO PTIENT INVOLVEMENT. AFTER DOING 3 GFE WE HAVEN'T RECEIVED ANY INFORMATION. AS OF NOW, THE INVESTIGATION IS CLOSED, IF ANY NEW INFORMATION IS RECEIVED FUTURE RELATED TO PART REPLACEMENT WILL REOPEN THE COMPLAINT AND UPDATE IT. H3 OTHER TEXT : NO REPAIR INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DAILY INSPECTION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT DID NOT PASS USER INSPECTION, AS SAFETY DISK LEAK 2 PNEUMATIC MODULE LEAK TEST DID NOT PASS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959279 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 Prefer Not To Disclose N/A.