BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22672805 · Received July 31, 2025

    Report

    Report Number
    2249723-2025-0003239
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 15, 2025
    Report Date
    October 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D1, D4 (VERSION OR MODEL #, CATALOG #, UNIQUE IDENTIFIER (UDI) #). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND THE FSE VERIFIED UPPER DISPLAY SHOWED SIGNIFICANT VIDEO ARTIFACT. ISOLATED FAILURE TO VIDEO GENERATOR PCB AND INVERTER PCB. REPLACED VIDEO GENERATOR PCB AND INVERTER PCB. LEFT ADDITIONAL 9V BATTERY WITH CUSTOMER FOR POTENTIAL FUTURE PREVENTIVE USE. VERIFIED PROPER CALIBRATION, PERFORMED FUNCTIONAL CHECK, AND SAFETY TEST, THEN RETURNED UNIT TO CUSTOMER FOR USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: 0040-00-0456 (KIT), 0670-00-1182, 0670-00-1183, AND 0012-00-1845. PARTS WERE RECEIVED WITH A REPORTED FAILURE OF THE UPPER DISPLAY GLITCHING AND SHOWING A DOUBLE IMAGE. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PARTS INDIVIDUALLY AND TOGETHER IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PARTS TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURES CAN BE CONFIRMED ON ANY PART. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS- B4, B5, G3, G6, H2, H11. CORRECTED FIELDS- E3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN CARDIOSAVE INTRA AORTIC BALLOON PUMP, THE WAS A SCREEN ISSUE WHERE, SCREEN APPEARED TO BE DOUBLED AND LOOKED LIKE ONE SET OF INFORMATION WAS ON TOP/OFFSET OF THE OTHER. THERE WAS NO PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444190 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female SENSATION PLUS