BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 12393604 · Received August 31, 2021

    Report

    Report Number
    2249723-2021-01968
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 6, 2021
    Report Date
    March 20, 2023
    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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF ACTUAL/SUSPECTED DEVICE: (10) A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE IDENTIFIED THE IABP UNIT WITH BATTERIES RETRIEVED, AND UNPLUGGED. THE FSE SEATED THE RESPECTIVE BATTERIES ON BAYS 1 AND 2. THE CONSOLE WAS SEATED INTO THE CART AND IMMEDIATELY THE FSE OBSERVED THE IABP UNIT COMMENCED CHARGING THE BATTERIES. AS THE CUSTOMER'S BIOMED OBSERVED THE AFOREMENTIONED SEQUENCE, INDICATED THE CONSOLE HAD BEEN UNHINGED FROM THE CART THE WHOLE TIME. THE BIOMED INDICATED THE IABP UNIT SLID IN AND OUT EASILY FROM THE CART, WHICH EXPLAINS WHY THE IABP UNIT FAILED TO CHARGE. THE FSE IDENTIFIED NOTHING UNUSUAL IN THE LOGS. THE BATTERIES WERE FULLY DEPLETED, THUS UNABLE TO COMPLETE A BATTERY RUNTIME. THE FSE OBSERVED THE BATTERIES; HOWEVER, CHARGE AT ABOUT 30K MWH, PER LED INDICATOR IN THE BATTERY WHICH POINTED TO A GOOD BATTERY. THE FSE LEFT THE IABP UNIT ON SERVICE MODE, DIAGNOSTIC SUPPORT, INTERNAL STATISTICS, POWER PARAMETERS SO THE BIOMED COULD MONITOR THE BATTERY CHARGING STATUS. THE FSE CONFIRMED WITH BIOMED TOWARDS END OF DAY THAT BATTERY 2 REACHED ABOUT 180K MWH, WHEN FULLY CHARGED, POINTING TO A GOOD CHARGE FOR THE BATTERY. THE FSE EXPLAINED EXTENT OF THE WORK COMPLETED TO BIOMED. ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS WERE PERFORMED. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. FULL EVENT SITE NAME: (B)(6) MEDICAL CENTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON UMP (IABP) WAS NOT CHARGING AND SHUTDOWN. THE USER SWAPPED OUT THE IABP CONSOLE TO CONTINUE TREATMENT. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292721 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 Prefer Not To Disclose UNKNOWN.