BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19299052 · Received May 13, 2024

    Report

    Report Number
    2249723-2024-01972
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    May 1, 2024
    Report Date
    February 5, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: E1(INITIAL REPORTER).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS), H10, H11 CORRECTED FIELDS: H6(MEDICAL DEVICE ¿ PROBLEM CODE) ADDITIONAL INFORMATION: E1(EVENT SITE POSTAL CODE - 3850022) IT WAS REPORTED THAT BEFORE USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THE TOUCH SCREEN IS NOT RESPONDING. GETINGE FIELD SERVICE ENGINEER (FSE) THE TOUCH SCREEN IS NOT WORKING. NO RECURRENCE TODAY, SO WE CLEANED AND WASHED THE TOUCH SCREEN AND CONNECTOR AS A PRECAUTION. AFTER TOUCH SCREEN CALIBRATION, WE PERFORMED A CHECK ON OPERATION. THERE WAS NO PATIENT INVOLVED.

    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).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THE TOUCH SCREEN IS NOT RESPONDING. THE UNIT WAS NOT IN CLINICAL USE, THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) THE TOUCH SCREEN IS NOT RESPONDING. THE UNIT WAS NOT IN CLINICAL USE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847296 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.