BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21916376 · Received April 28, 2025

    Report

    Report Number
    2249723-2025-0001967
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Report Date
    November 4, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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, D9, E1 (EVENT SITE EMAIL AND INITIAL REPORTER), G1 (CONTACT PERSON MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: B5, H6 (HEALTH EFFECT CLINICAL AND IMPACT CODE). A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE DEVICE AND REPLACED POWER MANAGEMENT BOARD (D670-00-1162). FUNCTIONAL/SAFETY TESTING COMPLETED PER MANUFACTURE RECOMMENDATIONS ALL TESTS PASSED RETURNED UNIT BACK TO CUSTOMER. COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 09 OCT 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0670-00-1162 PCB, POWER MANAGEMENT, ROHS SERIAL NUMBER: (B)(6)_SWEMCO WITH A REPORTED UNIT FAILURE OF POWER SUPPLY ISSUE. 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: 0670-00-1162 PCB, POWER MANAGEMENT, ROHS SERIAL NUMBER: (B)(6)_SWEMCO INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER: (B)(6) AND TESTED THE BOARD 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. COULD NOT REPLICATE THE POWER SUPPLY ISSUE. THE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT DEPT. PER PROCEDURE NUMBER: 0002-07-D008 REV.AU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD POWER SUPPLY ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD POWER SUPPLY ISSUE. THERE WAS PATIENT INVOLVEMENT HOWEVER, NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756636 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