BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18934465 · Received March 19, 2024

    Report

    Report Number
    2249723-2024-01180
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    March 7, 2024
    Report Date
    December 26, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H10, H11. CORRECTED FIELDS: E2, E3, G2. ADDITIONAL INFORMATION: EVENT SITE POSTAL CODE: 7920831. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. TO FIX THE ISSUE, THE FSE REPLACED TOUCHSCREEN PANEL ASSY, AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED AND CLEARED FOR CLINICAL SERVICE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTION BLOCK E1 EVENT SITE NAME IS (B)(6) HOSPITAL. CORRECTED FIELDS: H6 (PROBLEM CODE, INVESTIGATION FINDINGS AND CONCLUSION). THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0160-00-0123 REV.D, SN: (B)(6) TOUCHSCREEN ASSY, 12.1¿¿ THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF TOUCHSCREEN NOT RESPONDING. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED TOUCHSCREEN ASSY, 12.1¿¿ INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. PERFORMED FUNCTIONAL TESTS AND PASSED. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF TOUCHSCREEN NOT RESPONDING. TOUCHSCREEN ASSY, PASSED TESTING. RETAINING TOUCHSCREEN ASSY, IN THE FAT DEPT. PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DAILY ROUTINE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS TOUCH PANEL DOES NOT RESPOND. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318078 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