BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19735432 · Received July 12, 2024

    Report

    Report Number
    2249723-2024-02842
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 24, 2024
    Report Date
    February 17, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, COMPONENT CODE). GETINGE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE BATTERIES WERE NOT CHARGING. UPON ARRIVAL, FSE FOUND THAT THE CHARGING CIRCUIT WOULD POWER ON AND OFF INTERMITTENTLY AND INSPECTED THE POWER SUPPLY IN THE HOSPITAL CART AND FOUND FLUID INTRUSION AROUND THE POWER SUPPLY. FSE REPLACED PART NUMBERS: (D012-00-1834) CABLE, HE TANK TRANSDUCER, (D014-0258) POWER SUPPLY, (D670-00-1166) POWER SUPPLY MONITOR, AND (D012-00-1688-21) AC POWER CORD. AFTER REPLACING THOSE PART NUMBERS BATTERIES STILL WOULD NOT CHARGE. AS A RESULT OF THE FLUID INTRUSION, THE POWER MANAGEMENT BOARD WAS SHORTED. REPLACED PART NUMBER (D670-00-1162) POWER MANAGEMENT AND THE BATTERIES BEGAN TO CHARGE AND PERFORMED A PM, FULL CALIBRATION, AND TESTED THE UNIT. THE PRODUCT PASSED ALL FUNCTIONAL/SAFETY TESTING. RETURNED THE UNIT TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE BATTERIES OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT DO NOT CHARGE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134278 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 N/A.