BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 21558016 · Received March 10, 2025

    Report

    Report Number
    2249723-2025-0001098
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 19, 2025
    Report Date
    December 31, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS : B4, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2,H3, H6 (HEALTH EFFECT ¿ CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS ), H11 CORRECTED FIELDS: E2. THE GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE PERFORMED ERROR ANALYSIS. TESTS PERFORMED IN SERVICE FOUND A COMPRESSOR MALFUNCTION. SECOND INTERVENTION REQUIRED TO REPLACE THE COMPRESSOR. DEVICE NOT USABLE. DURING SECOND INTERVENTION, COMPRESSOR REPLACEMENT HAS BEEN CARRIED OUT. CALIBRATIONS AND CHECKS PERFORMED AS PER MANUFACTURER'S PROCEDURES. ELECTRICAL SAFETY AND CORRECT OPERATION CHECKS. THE FSE STATES THAT THE REASON FOR REPLACING SPARE PARTS IS THAT BROKEN COMPRESSOR. OPERATION TESTS PERFORMED WITH POSITIVE OUTCOME.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11. CORRECTION: D9, H11. THE GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE PERFORMED ERROR ANALYSIS. TESTS PERFORMED IN SERVICE FOUND A COMPRESSOR MALFUNCTION. SECOND INTERVENTION REQUIRED TO REPLACE THE COMPRESSOR. DEVICE NOT USABLE. DURING SECOND INTERVENTION, COMPRESSOR REPLACEMENT HAS BEEN CARRIED OUT. CALIBRATIONS AND CHECKS PERFORMED AS PER MANUFACTURER'S PROCEDURES. ELECTRICAL SAFETY AND CORRECT OPERATION CHECKS. THE FSE STATES THAT THE REASON FOR REPLACING SPARE PARTS IS THAT BROKEN COMPRESSOR. OPERATION TESTS PERFORMED WITH POSITIVE OUTCOME.THE FOLLOWING WAS PERFORMED BY (B)(6), SR SERVICE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. WAYNE, NJ (B)(4) 18-MAR-2025. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART P/N: 0119-00-0236 S/N: (B)(6) TECH SCROLL COMPRESSOR. THE FAT DEPARTMENT PERFORMED A VISUAL INSPECTION OF THE PART RECEIVED AND FOUND THAT THE PART IS IN GOOD CONDITION. THE FAT DEPARTMENT INSTALLED P/N: 0119-00-0236 S/N: (B)(6) IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED TO FACTORY SPECIFICATIONS PER CARDIOSAVE SERVICE MANUAL NUMBER (B)(4) REVISION R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT FOUND THAT THE COMPRESSOR IS RATTLING AND MAKING A GRINDING SOUND. THE COMPRESSOR IS DEFECTIVE. RETAINING THE SCROLL COMPRESSOR IN THE FAT DEPT. PER PROCEDURE (B)(4) REV AT.

    Additional Manufacturer Narrative · 0

    DUE CHARACTER LIMIT E1. INITIAL REPORTER NAME- (B)(6). EVENT SITE NAME-(B)(6). 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 BEFORE USE CARDIOSAVE INTRA AORTIC BALLOON PUMP(IABP), HAD AUTOFILL FAILURE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821939 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown