BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 15188472 · Received August 8, 2022

    Report

    Report Number
    2249723-2022-01991
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 22, 2022
    Report Date
    July 4, 2025
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE OBSERVED THAT THE BATTERIES COULD NOT BE DETECTED. ALSO, THE FSE OBSERVED THAT THERE WAS LIQUID PENETRATION INTO THE UNIT (WHITE COMPOUNDS FOUND ONTO UNIT INNER BASE). SO, IN ORDER TO FIX THE ISSUE THE FSE REPLACED THE PCB POWER MANAGEMENT (0670-00-1162) AND ASSY UNSHIELDED PWR SLOT BD INTERFACE (0997).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6 (MEDICAL DEVICE ¿ PROBLEM CODE, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D4 (UNIQUE IDENTIFIER (UDI)). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE OBSERVED THAT THE BATTERIES COULD NOT BE DETECTED. ALSO, THE FSE OBSERVED THAT THERE WAS LIQUID PENETRATION INTO THE UNIT (WHITE COMPOUNDS FOUND ONTO UNIT INNER BASE). SO, IN ORDER TO FIX THE ISSUE, THE FSE REPLACED THE PCB POWER MANAGEMENT (0670-00-1162) AND ASSY UNSHIELDED PWR SLOT BD INTERFACE (0997-00-1189). THE UNIT PASSED ALL MANIFOLD TESTS AND OPERATED AS NORMAL. THE UNIT WAS THEN HANDED OVER TO CUSTOMER IN GOOD WORKING CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM SHUTDOWN WITH A BEEP SOUND. THE UNIT WAS SWAPPED OUT IMMEDIATELY TO CONTINUE THERAPY. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379265 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.