BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21373489 · Received February 13, 2025

    Report

    Report Number
    2249723-2025-0000680
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 21, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, E1-EVENT SITE EMAIL, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: D10. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE NOTICED THAT THE BATTERIES WERE CHARGING VIA THE SERVICE MENU WHILE CONNECTED TO AC POWER. THE FSE CONFIRMED THAT THE MWH CAPACITY WOULD DROP FOR EACH INDIVIDUAL BATTERY, AND THEN THEY WOULD MOMENTARILY BEGIN TO RAISE FOR A FEW MINUTES. THEY WOULD THEN DROP AGAIN. THE FSE REPLACED THE POWER MANAGEMENT BOARD. THE FSE CONFIRMED THAT THE MWH WAS STEADILY INCREASING. BOTH BATTERIES WERE ABLE TO GAIN CHARGE CONSISTENTLY. THE UNIT PASSED ALL PERFORMANCE AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER. THE FOLLOWING INVESTIGATION WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART PCB, POWER MANAGEMENT, ROHS SWEMCO WITH A REPORTED UNIT FAILURE OF THE UNIT WASN'T CHARGING FULLY. 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 PCB, POWER MANAGEMENT, ROHS SWEMCO INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. THE FAT DEPT. COULD NOT REPLICATE THE COMPLAINT OF THE UNIT WASN'T CHARGING FULLY. THE BOARD PASSED TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD CHARGING ISSUE UNIT WASN'T CHARGING FULLY. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902652 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.| UNKNOWN.