BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID W/ E/F PLUG

    MDR report key: 15314842 · Received August 29, 2022

    Report

    Report Number
    2249723-2022-02204
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 29, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108414
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, E1-(SITE COUNTRY), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10, H11. ADDITIONAL CONTACT INFORMATION: (B)(6). IT WAS REPORTED DURING THAT BEFORE USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT POWER CABLE COULD NOT BE RETRACTED DUE TO BAD SPRING AND SOMEONE TRIED TO PUSH INSIDE. THE CABLE GOT STUCK AND NOT USABLE ANYMORE. AT THE SAME TIME THE UNIT STARTED BEHAVING VERY STRANGE WHEN PLUGGED TO 220V. ON BATTERY WITHOUT 220V WORKS OK. WHEN PLUGGED IN, IT KEEPS BEEPING, FREEZES THE SCREEN, CANNOT BE TURNED OFF ON GREEN BUTTON AND CANNOT LOAD SOFTWARE IF STARTED WITH 220V PUGGED IN. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE POWER MANAGEMENT BOARD AND LINE CORD ASSEMBLY UNIT IS IN FULL WORKING ORDER. NO PATIENT WAS INVOLVED THERE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: REV. H, SN: 21 (B)(6), POWER MANAGEMENT BOARD, REV. Q, SN: (B)(6), LINE CORD ASSEMBLY. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND: HAS WHITE RESIDUE ON THE BOARD. BASED ON PAST EXPERIENCE, THIS RESIDUE IS CONSISTENT WITH SALINE. CAPA (B)(4) HAS BEEN INITIATED TO ADDRESS THIS ISSUE. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED. HAS THE CONNECTOR CABLES CUT OFF. CANNOT BE INSTALLED INTO A TEST FIXTURE DUE TO THE DAMAGE CAUSE BY THE SALINE AND THE RISK IT POSES TO THE TEST FIXTURE. DUE TO THIS RISK, THE FAT CANNOT INVESTIGATE THIS PART ANY FURTHER. HAS DAMAGE TO THE WIRING AND CANNOT BE INSTALLED INTO THE TEST FIXTURE. FAT CANNOT INVESTIGATE THIS PART ANY FURTHER. FAT COULD NOT VERIFY THE REPORTED ISSUES WITH THIS COMPLAINT. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AP. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS "NOT CONFIRMED".

    Additional Manufacturer Narrative · 0

    THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS "IMPOSSIBLE TO DEFINE."

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE POWER MANAGEMENT BOARD AND LINE CORD ASSEMBLY. UNIT IS IN FULL WORKING ORDER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: EDM, POWER MANAGEMENT BOARD, LINE CORD ASSEMBLY. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND: HAS WHITE RESIDUE ON THE BOARD. BASED ON PAST EXPERIENCE, THIS RESIDUE IS CONSISTENT WITH SALINE. CAPA 14-CA-0097 HAS BEEN INITIATED TO ADDRESS THIS ISSUE. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED. HAS THE CONNECTOR CABLES CUT OFF. CANNOT BE INSTALLED INTO A TEST FIXTURE DUE TO THE DAMAGE CAUSE BY THE SALINE AND THE RISK IT POSES TO THE TEST FIXTURE. DUE TO THIS RISK, THE FAT CANNOT INVESTIGATE THIS PART ANY FURTHER. HAS DAMAGE TO THE WIRING AND CANNOT BE INSTALLED INTO THE TEST FIXTURE. FAT CANNOT INVESTIGATE THIS PART ANY FURTHER. FAT COULD NOT VERIFY THE REPORTED ISSUES WITH THIS COMPLAINT. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AP. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS "IMPOSSIBLE TO DEFINE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DUE TO BAD SPRING, THE POWER CABLE COULD NOT BE RETRACTED AND SOMEONE TRIED TO PUSH INSIDE. THE CABLE GOT STUCK AND NOT USABLE ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615636 CARDIOSAVE HYBRID W/ E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-55 10607567108414

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose UNKNOWN.