BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17192145 · Received June 23, 2023

    Report

    Report Number
    2249723-2023-02920
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 13, 2023
    Report Date
    April 6, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4,D9,E1(EVENT SITE STATE - HIROSHIMA,EVENT SITE POSTAL CODE - 721-0971),G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION,INVESTIGATION FINDINGS,COMPONENT CODE,INVESTIGATION CONCLUSIONS),H10,H11. CORRECTED FIELDS - D5,E2,E3,G2. A GETINGE FIELD SERVICE ENGINEER OPERATION INSPECTION HAS BEEN CARRIED OUT. DUE TO LIQUID (PHYSIOLOGICAL SALINE) INTRUDING INTO THE INSIDE OF THE DEVICE, PARTS WERE REPLACED AND THE INSIDE WAS CLEANED.REPLACEMENT OF POWER SLOT INTERFACE. REPLACEMENT OF FAN. REPLACEMENT OF LITHIUM-ION BATTERY (2 PIECES).AFTER EACH WORK, WE CHECKED THE OPERATION BASED ON THE INSPECTION RECORD SHEET AND CONFIRMED THAT IT IS CURRENTLY IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) PHYSIOLOGICAL SALINE WAS SCATTERED IN THE EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757957 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown