BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20266290 · Received September 20, 2024

    Report

    Report Number
    2249723-2024-0003850
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 7, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED FIBER OPTIC CONNECTOR (D012-00-1562) WHICH RESOLVED THE ISSUE. FSE COMPLETED THE PERFORMANCE AND SAFETY MEASUREMENTS. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS PERFORMED. UNIT WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED FIBER OPTIC EXTENSION CONNECTOR (0012-00-1562) REV H, SERIAL NUMBER: (B)(6). THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF CONNECTOR BROKEN. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND FOUND FIBER OPTIC CONNECTION PORT WAS NOT IN GOOD CONDITION (BROKEN). THE FAILURE ANALYSIS AND TESTING DEPARTMENT VERIFIED THE FAILURE MESSAGE OF CONNECTOR BROKEN. RETAINING FIBER OPTIC EXTENSION CONNECTOR IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AR. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    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) FIBER OPTIC CONNECTOR IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226532 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