BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18372559 · Received December 21, 2023

    Report

    Report Number
    2249723-2023-05424
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Report Date
    October 2, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5)

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: D4. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THEY WERE ABLE TO CONFIRM THE ISSUE. THEY NARROWED THE ISSUE TO THE COMPRESSOR, AND SUBSEQUENTLY REPLACED THE COMPRESSOR. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0670-00-1163 REV. A, SN: (B)(6). PN: 0119-00-0236 REV. C, 23 12646 04_DTECH. THESE PARTS WERE RECEIVED WITH A REPORTED FAILURE OF THE BACKPLANE BOARD NOT GIVING AUDIBLE PROMPTS ON BOOTUP. COMPRESSOR FAILED TO PUMP. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED PN: 0670-00-1163 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. VERIFIED THE FAILURE OF THE BOARD NOT HAVING AUDIBLE PROMPTS ON BOOTUP BUT NO ROOT CAUSE DEFINED. THE SUPPLIER CANNOT TEST THIS REVISION FOR FURTHER FAILURE ANALYSIS. THE FAT INSTALLED PN: 0119-00-023 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. RAN THE PUMP FOR 1 HOUR WITH NO ISSUES. FAT COULD NOT CONFIRM THE REPORTED FAILURE ON THIS PART. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM),THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BACKPLANE BOARD BUZZER FAILED TO PROVIDE POWER UP AUDIBLE PROMPTS WHEN FIRST POWERING UP AND ONCE FINALLY BOOTED UP. IABP ALSO FAILED TO PUMP WHEN INITIALLY TESTED WITH A TESTING CATHETER AND TRAINER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051922 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown