BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 14105678 · Received April 13, 2022

    Report

    Report Number
    2249723-2022-00847
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 21, 2022
    Report Date
    July 26, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FSE EVALUATED UNIT AND OBSERVED BATTERY 1 SHOWED 38650 MWH FOR 5 LEDS OF CHARGE, WHICH WOULD CORRELATE WITH THE BATTERY SHOWING LOW BATTERY IMMEDIATELY AFTER COMMENCING BATTERY RUNTIME. NOTHING UNUSUAL WAS IN THE LOGS. FSE REPLACED BATTERIES AS A PAIR AND COMPLETED PM. UNIT WAS CALIBRATED AND PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. THE FULL EVENT SITE NAME IN IS (B)(6). THE INITIAL REPORTER NAMED IN IS A GETINGE EMPLOYEE WHO HAS DIFFERENT CONTACT DETAILS FROM THAT OF THE EVENT SITE. A CONTACT PERSON AT THE EVENT SITE IS (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE) THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BATTERY SHOWED FULL LEDS OF CHARGE WHEN UNIT WAS INITIALLY TESTED AND COMMENCED BATTERY RUNTIME TEST. AFTER ABOUT TWO MINUTES OF BATTERY RUNTIME BATTERY 1 SHOWED 3 LEDS OF CHARGE, ALARMED LOW BATTERY, AND LESS THAN 25 MINUTES OF RUNTIME ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563607 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.