BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21583455 · Received March 12, 2025

    Report

    Report Number
    2249723-2025-0001190
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 25, 2025
    Report Date
    June 5, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, G3, G6, H2, H3, H6 (COMPONENT CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) DUPLICATED ISSUE OF UNIT NOT ABLE TO POWER UP REPLACED DAMAGED COMPONENTS IN LCD FROM IPX WATER TESTING AND DEFECTIVE EXECUTIVE PROCESSOR PCB, COIL CABLE AND NYLON P-CLIP. PERFORMED PASSING FULL FUNCTIONAL CHECK AND RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION IN BLOCK E1: (B)(6).

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER DURING TESTING THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) COILED CORD CONNECTED TO VIDEO GENERATOR BOARD WAS FRAYED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399481 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.