BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 12159349 · Received July 13, 2021

    Report

    Report Number
    2249723-2021-01505
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 18, 2021
    Report Date
    September 19, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, G7, H2, H6(INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: G1(CONTACT PERSON), H3, H6(INVESTIGATION TYPE & COMPONENT CODES) H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.

    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 USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD NO POWER. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    TESTING OF ACTUAL/SUSPECTED DEVICE: 10/3223): A GETINGE STM HAS CONFIRMED WITH THE CUSTOMER VIA TELEPHONE THAT THE DEVICE NEEDED TO BE RESEATED INTO CART, THE DEVICE WAS NOT CHARGING DUE TO CONSOLE NOT BEING FULLY ENGAGED INTO CART. AFTER LETTING DEVICE SIT FOR A NIGHT, THE DEVICE FULLY CHARGED UP WAS PUT BACK INTO SERVICE, THERE WAS NO FURTHER ACTION NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD NO POWER. IT IS UNKNOWN THE CIRCUMSTANCES UNDER WHICH THE EVENT OCCURRED. IT IS ALSO UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. HOWEVER, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057296 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