BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 22724637 · Received August 6, 2025

    Report

    Report Number
    2249723-2025-0003386
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 24, 2025
    Report Date
    January 16, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, H3, D9, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). GETINGE FIELD SERVICE ENGINEER WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE WAS ABLE TO NARROW THE FAILURE TO THE SPECIFICATION ASSEMBLY, LCD (0160-00-0123), ASSY, DISPLAY TOP (0160-00-0127) AND REPLACED THE PARTS. THE UNIT UNDERWENT FUNCTIONAL AND SAFETY TESTS TO ENSURE THE FUNCTION OF THE DEVICE. THE UNIT PASSED AND RETURNED TO NORMAL USE.THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 24 NOV 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0160-00-0123 ASSEMBLY LCD SERIAL NUMBER (B)(6). PART NUMBER 0160-00-0127 ASSY, DISPLAY TOP SERIAL NUMBER N/A. PART NUMBER 0334-00-1809 LABEL, UPPER INSIDE BADGE SERIAL NUMBER N/A. PART NUMBER 0334-00-1810-01 LABEL ID SERIAL NUMBER N/A. PLEASE NOTE: LABELS WERE SENT BACK FOR UNKNOWN REASON. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF; SCREEN HAS A DEAD PIXEL. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE DISPLAYS TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0160-00-0123 ASSEMBLY LCD SERIAL NUMBER (B)(6) AND PART NUMBER 0160-00-0127 ASSY, DISPLAY TOP SERIAL NUMBER N/A INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE DISPLAYS TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(4) REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT. OBSERVED ONE DEAD PIXEL RIGHT ABOVE THE HELP BUTTON ON PART NUMBER 0160-00-0123. PART NUMBER PART NUMBER 0160-00-0127 ASSY, DISPLAY TOP SERIAL NUMBER N/A PASSED TESTING. NO DEAD PIXELS WERE OBSERVED ON THIS DISPLAY. THE DISPLAY PASSED TESTING. RETAINING THE DISPLAYS IN THE FAT D PER PROCEDURE NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION E1, INITIAL REPORTER FULL NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FIELD SERVICE ENGINEER (FSE) THAT DURING CHECK-UP OF NEW UNIT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD DEAD PIXEL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765014 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown