BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22103095 · Received May 29, 2025

    Report

    Report Number
    2249723-2025-0002395
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 15, 2025
    Report Date
    August 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4; D9; G3; G6; H2; H6 PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, COMPONENT CODE; H11. CORRECTED FIELDS: G1 CONTACT PERSON ¿ MFG SITE A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPLACED THE BLOOD PRESSURE CABLE ASSEMBLY (D012-00-1815) TO RESOLVE THE ISSUE. COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE FOLLOWING WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT WAYNE, NJ: (B)(6) 09 JULY 2025. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0012-00-1815 SN: (B)(6). THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF PRESSURE CABLE NOT WORKING. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND; THE PINS LOOSEN. INSTALLED BP CABLE INTO THE CARDIOSAVE TEST FIXTURE SN: (B)(6) AND TESTED TO THE CARDIOSAVE SERVICE MANUAL PN: 0070-00-0639 REVISION R. PERFORMED FIBER OPTIC TESTS AND THE BP CABLE DID NOT WORK. THE FAT DEPT, DID NOT SEE THE TRANSDUCER WAVEFORM SIGNAL ON DISPLAY. THE FAT DEPT. VERIFIED THE FAILURE MESSAGE OF CABLE NOT WORKING. CABLE BP TRANSDUCER ADAPTER FAILED TESTING. RETAINING CABLE IN THE FAT DEPT. PER PROCEDURE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) PRESSURE CABLE WAS NOT WORKING. THERE WAS NO PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD PRESSURE CABLE NOT WORKING. THE CUSTOMER IS UNAWARE OF ANY PATIENT INVOLVEMENT HOWEVER, NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530144 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 UNKNOWN.