BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 19366777 · Received May 21, 2024

    Report

    Report Number
    2249723-2024-02096
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    May 10, 2024
    Report Date
    April 2, 2025
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). IT WAS BEING REPORTED THAT DURING A ROUTINE CHECK THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) HAD AN ISSUE REGARDING THE "BATTERY NO INDICATOR". A GETINGE FIELD SERVICE ENGINEER (FSE) WAS BEING DISPATCHED IN ORDER TO EVALUATE THE UNIT AND DURING THE PERIOD OF AN EVALUATION IT WAS BEING FOUND THAT THE POWER CORD CABLE AT MIDDLE HAS WIRE (N) WHICH IS UNDER THE OPEN ISSUE. THEN THE FSE HAD REPLACED THE REEL, AC POWER CORD, BS1363 "TYPE G", TD AND TESTED THE WORKING CONDITION WHICH IS OK AND THE ESA TEST HAD ALSO BEEN PASSED. THERE IS NO INVOLVEMENT OF THE PATIENT DURING THIS INCIDENT. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0012-00-1688-24 REV. Q, SN 21 07_AMETEK WITH A REPORTED UNIT FAILURE OF A FAULTY POWER CORD. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. TESTED THE CORD AND FOUND ONE OF THE WIRES TO BE FAULTY AND OPEN. CONFIRMED THE FAILURE BUT NO ROOT CAUSE IDENTIFIED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AQ. THE NON-CONFORMANCE'S WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INVESTIGATION WAS PERFORMED BY, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART AMETEK WITH A REPORTED UNIT FAILURE OF A FAULTY POWER CORD.THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION.TESTED THE CORD AND FOUND ONE OF THE WIRES TO BE FAULTY AND OPEN. CONFIRMED THE FAILURE BUT NO ROOT CAUSE IDENTIFIED.RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, G3, G6, H2, H11. CORRECTED FIELDS: D4 (UDI), H6 (TYPE OF INVESTIGATION, INVESTIGATION CONCLUSION).

    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

    N/A.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE CHECK THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD NO BATTERY INDICATOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426368 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown