BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20347534 · Received October 1, 2024

    Report

    Report Number
    2249723-2024-0004001
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 9, 2024
    Report Date
    October 25, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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) HAD A PHONE CALL FROM A CATH LAB NURSE AT THE EVENT SITE, FOR ASSISTANCE WITH HELIUM TRANSDUCER NOT CALIBRATED ALARM DURING USE. AS THEY STARTED TO TROUBLESHOOT, THE NURSE STATED SAID, ¿OH, I¿VE ALREADY SWITCHED THE CONSOLES OUT. I JUST WANTED TO SEE IF SOMETHING WAS WRONG WITH THIS ONE IN CASE WE HAVE AN OVERNIGHT EMERGENCY.¿ FSE HAD ASKED THE NURSE TO CHECK THE HELIUM GAUGE; SHE SENT OVER A PHOTO OF THE IT WHICH SHOWED THAT THE TANK WAS OVER HALF FULL. FSE EXPLAINED THE NATURE OF THE ALARM AND GAVE HER THE INFORMATION REGARDING THIS ALARM FROM THE IFU. FSE ALSO SENT OVER A SCREEN SHOT OF THIS PORTION OF THE IFU FOR THEIR REFERENCE. THE NURSE HAD TAKEN THE PUMP DOWN TO THE CATH LAB AND WAS WITH HER CHARGE NURSE. FSE RE-EXPLAINED THE SITUATION AND SUGGESTED TO TAKE THE PUMP TO BIOMED TO BE SERVICED IF THEY HAD BACKUPS. THE CHARGE NURSE SAID ¿OH YES, WE HAVE PLENTY OF PUMPS.¿ THE NURSE LABELED THE PUMP AND TOOK IT TO BIOMED. THE STAFF WAS APPRECIATIVE OF THE SUPPORT AND HAS FSE CONTACT FOR ANY OTHER QUESTIONS. LATER THIS ISSUE WAS CORRECTED BY CUSTOMER'S BIOMEDICAL ENGINEERING DEPARTMENT BY CALIBRATING HELIUM TRANSDUCERS.

    Description of Event or Problem · 0

    A CATH LAB NURSE, CALLED FOR ASSISTANCE WITH A HELIUM TRANSDUCER NOT CALIBRATED ALARM ON A CARDIOSAVE DURING USE. CONSOLE WAS SWITCHED OUT. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44266 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 54 YR Male UNKNOWN.