BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22222034 · Received June 17, 2025

    Report

    Report Number
    2249723-2025-0002628
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 2, 2025
    Report Date
    October 17, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMITATION (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS- B4, B5, G3, G6, H2, H11. CORRECTED FIELDS- H6 MEDICAL DEVICE ¿ PROBLEM CODE, INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED THE FIBER OPTICS CABLE ASSEMBLY. ALL FUNCTIONAL AND SAFETY CHECKS ARE MET TO FACTORY SPECIFICATIONS. UNIT WAS RETURNED TO CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: CABLE ASSY, FO SENSOR. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF BROKEN FO CONNECTOR. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND VERIFIED THE FAILURE MESSAGE OF BROKEN FO CONNECTOR. RETAINING CABLE ASSY. FO SENSOR IN THE FAT DEPT. PER PROCEDURE. PER CAPA 792593 THE FIBER OPTIC ADAPTER CONNECTOR (ITEM 14) OF THE CABLE ASSEMBLY, FO SENSOR EXTENSION IS NOT ROBUST ENOUGH TO CONSISTENTLY WITHSTAND LARGE AND/OR REPEATABLE FORCE/IMPACT THAT THE CONNECTOR MAY BE SUBJECTED TO OVER THE COURSE OF CONTINUED USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD FIBEROPTIC LATCH BROKEN FIBEROPTIC LATCH BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540026 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 NA.