BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22024491 · Received May 15, 2025

    Report

    Report Number
    2249723-2025-0002225
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    May 1, 2025
    Report Date
    October 10, 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
    BIOMEDICAL ENGINEER
    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, G3, G6, H2, H3, H6 (INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. CORRECTED FIELD: H6 (MEDICAL DEVICE ¿ PROBLEM CODE). FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT WAYNE, NJ: SR 20 JUNE 2025. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0670-00-1183 REV D, SN: (B)(6) _EDM UPPER DISPLAY MONITOR BOARD. PN: 0160-00-0127 SN: (B)(6) DISPLAY TOP LCD. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF DISPLAY NOT FUNCTIONING, INOPERABLE AND BLACK SCREEN. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION, AND PARTS LOOK TO IN GOOD CONDITION. INSTALLED UPPER DISPLAY MONITOR BOARD AND DISPLAY TOP LCD INTO THE CARDIOSAVE TEST FIXTURE SN: (B)(6) AND TESTED TOGETHER AND SEPARATELY TO THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION R. THE FAT DEPT. PERFORMED DISPLAY CALIBRATION AND PASSED. THE FAT DEPT. PUMPED THE CARDIOSAVE TEST FIXTURE AND DID NOT OBSERVE DISPLAY NOT FUNCTIONING, INOPERABLE AND BLACK SCREEN. THE FAT DEPT. COULD NOT VERIFY THE FAILURE MESSAGE OF DISPLAY NOT FUNCTIONING, INOPERABLE AND BLACK SCREEN. BOTH PARTS PASSED TESTING. RETAINING BOTH PARTS IN THE FAT DEPT. PER PROCEDURE 0002-007-D008 REV AU. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND UPON INSPECTION UNIT¿S DISPLAY WAS INTERMITTENTLY INOPERABLE AND SHOWING A BLACK SCREEN. NO SIGNS OF DAMAGE OR USER ABUSE. PROCEEDED TO REPLACE CARDIOSAVE ROHS UPPER DISPLAY MONITOR AND TOP ASSEMBLY DISPLAY LCD ROHS. REPLACED THE GROUNDING STRAP CABLE OUT OF PRECAUTION. CARDIOSAVE DISPLAY WAS THEN FUNCTIONAL TO FACTORY SPECIFICATIONS. DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. DEVICE WAS RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING ROUTINE CHECK, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS INTERMITTENTLY INOPERABLE AND SHOWING A BLACK SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600788 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