BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21558010 · Received March 10, 2025

    Report

    Report Number
    2249723-2025-0001096
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 19, 2025
    Report Date
    October 9, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ (B)(6) 05 JUNE 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0160-00-0123 TOUCH SCREEN SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF TOUCH SCREEN NOT RESPONDING. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0160-00-0123 TOUCH SCREEN SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE TOUCH SCREEN TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT. OBSERVED THAT THE CARDIOSAVE WOULD NOT BOOT UP WITH A BLANK TOUCHSCREEN. THE FAT DEPT. WAS ABLE TO CONFIRM THE COMPLAINT THAT THE TOUCH SCREEN WAS NOT RESPONDING. THE TOUCH SCREEN FAILED TESTING. RETAINING THE TOUCH SCREEN IN THE FAT PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, E1, G1, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. DUE TO CHARACTER LIMIT IN E1: FULL INITIAL NAME: (B)(6). A GETINGE FIELD SERVICE ENGINEER EVALUATED THE DEVICE, HE WAS ABLE TO REPRODUCE THE CUSTOMER STATED COMPLAINT. HE REPLACED THE TOUCH SCREEN, CALIBRATED, FUNCTIONAL TESTING AND RESOLVED PROBLEM. CARDIOSAVE IABP SERVICES COMPLETED. SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART TOUCH SCREEN INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE TOUCH SCREEN TO FACTORY SPECIFICATIONS PER PROCEDURE REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART. THE FAT DEPT. OBSERVED THAT THE CARDIOSAVE WOULD NOT BOOT UP WITH A BLANK TOUCHSCREEN. THE FAT DEPT. WAS ABLE TO CONFIRM THE COMPLAINT THAT THE TOUCH SCREEN WAS NOT RESPONDING. THE TOUCH SCREEN FAILED TESTING. RETAINING THE TOUCH SCREEN IN THE FAT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THAT A CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD TOUCHSCREEN MALFUNCTION. NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821933 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.