BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21280884 · Received January 31, 2025

    Report

    Report Number
    2249723-2025-0000457
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 14, 2025
    Report Date
    April 3, 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

    UPDATE FIELDS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS ABLE TO REPRODUCE THE REPORTED MALFUNCTION. THE MWH CAPACITY WAS DROPPING FOR BOTH BATTERIES EVEN WHILE CONNECTED TO AC POWER. THE FSE REPLACED THE POWER MANAGEMENT BOARD (0670-00-1162). THE UNIT WAS CONNECTED TO AC POWER FOR ONE HOUR, AND THE FSE CONFIRMED THAT THE MWH WAS INCREASING. BOTH BATTERIES WERE CHARGING. THE UNIT PASSED ALL PERFORMANCE AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 WITH A REPORTED UNIT FAILURE OF THE BATTERIES NOT CHARGING. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE BOARD IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. BATTERIES WERE ABLE TO CHARGE IN BOTH BAYS. NO FAILURE CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP'S (IABP) BATTERIES WILL NOT FULLY CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150869 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