BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 21907537 · Received April 25, 2025

    Report

    Report Number
    2249723-2025-0001946
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 14, 2025
    Report Date
    November 22, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION IN E1 FOR EVENT SITE NAME, EVENT SITE NAME - (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9, G1, G3, G6, H2, H3, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE PARTS (BACKPLANE BOARD, VIDEO GENERATOR BOARD) ASSOCIATED WITH THIS COMPLAINT. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF BALLOON PRESSURE CANNOT BE DISPLAY. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION AND FOUND SALINE AND RUST ON BOTH SPEAKERS AND DUST UNDER THE FAN COMPARTMENT ON VIDEO GENERATOR BOARD. BACKPLANE BOARD LOOKS IN GOOD CONDITION. DUE TO RUST, SALINE AND DUST ON BOARD, THE FAT DEPARTMENT CANNOT BE INVESTIGATING VIDEO GENERATOR BOARD WITH CARDIOSAVE TEST FIXTURE. IT MIGHT HARM AND DAMAGE OTHER PARTS IN CARDIOSAVE TEST FIXTURE. INSTALLED BACKPLANE BOARD INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE CARDIOSAVE SERVICE MANUAL. PERFORMED FUNCTIONAL TESTS AND PASSED. ALSO, PUMPED THE CARDIOSAVE TEST FIXTURE AND COULD NOT VERIFY THE FAILURE MESSAGE OF BALLOON PRESSURE CANNOT BE DISPLAYED. BACKPLANE BOARD PASSED TESTING. RETAINING BOTH BOARDS IN THE FAT DEPARTMENT PER PROCEDURE 0002-07-D008 REV AU. DUE TO SALINE AND RUST ON VIDEO GENERATOR BOARD, THIS BOARD IS NOT GOING BACK TO SUPPLIER FOR FURTHER INVESTIGATION. BACKPLANE BOARD: - NOT CONFIRMED VIDEO GENERATOR BOARD: - USER - OPERATIONAL CONTEXT. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE CONDUCTED AN INSPECTION OF THE EQUIPMENT AND FAULT CODE RECORDS. THE FSE REPLACED THE PCB, BACKPLANE, ROHS (0670-00-1163) AND KIT, DISPLAY MONITOR TO VIDEO GEN BOARD (0040-00-0456). COMPLETED WITH FULL PERFORMANCE AND SAFETY CHECK TO FACTORY SPECIFICATIONS. RETURNED TO THE CUSTOMER AND CLEARED FOR CUSTOMER USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP'S (IABP) BALLOON PRESSURE CANNOT BE DISPLAYED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617664 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown