BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20510028 · Received October 22, 2024

    Report

    Report Number
    2249723-2024-0004336
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 30, 2024
    Report Date
    May 7, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND CONFIRMED THE ISSUE. THE FSE REPLACED THE POWER MANAGEMENT PCB, ONCE REPLACED CHARGE INDICATOR LED CAME ON AND THEN IMMEDIATELY SHUT OFF. INSPECTED THE PMB AND FOUND THAT THE BOARD HAD BEEN DAMAGED WHEN POWERED ON. THE POWER MANAGEMENT PCB DID NOT CORRECT THE ISSUE. ONCE THE FSE REPLACED THE BACKPLANE BOARD (0670-00-1163) AND REASSEMBLED THE UNIT, THE FSE WAS ABLE TO TEST THE CHARGING CIRCUIT. ONCE POWERED ON AND BATTERIES INSTALLED, THE UNIT DID START THE CHARGING PROCESS. THE REMAINING PARTS WERE REPLACED DUE TO HOURS AND CYCLE DEMANDS. THE ONLY PART THAT WAS REPLACED FOR THE ISSUE WAS THE BACKPLANE PCB. THE ORIGINAL POWER MANAGEMENT BOARD WAS REINSTALLED. THE FSE ALSO REPLACED THE BATTERIES, SAFETY DISK (0202-00-0140), TIDAL VOLUME DISK (0202-00-0142) AND THE 9V BATTERY (0146-00-0146) DUE TO THE CYCLES AND HOURS. COMPLETED ALL CALIBRATIONS, PERFORMANCE AND SAFETY TESTS WITH NO FURTHER ISSUES. THE UNIT WAS APPROVED FOR CLINICAL USE AND RETURNED TO CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1163 PCB, BACKPLANE, ROHS SERIAL NUMBER (B)(6) SWEMCO WITH A REPORTED UNIT FAILURE OF BATTERY WON'T CHARGE. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-1163 PCB, BACKPLANE, ROHS SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(4) REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT. COULD NOT REPLICATE THE COMPLAINT OF THE BATTERY NOT CHARGING. BATTERIES CHARGED TO FACTORY SPECIFICATIONS WITH NO PROBLEM FOUND. THE BACKPLANE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT DEPT. PER PROCEDURE (B)(4) REV.AS. BASED ON THE INFORMATION IN THE COMPLAINT AND THE EVALUATION BY THE FAT, NO ROOT CAUSE CAN BE DETERMINED AS THE FAT WAS NOT ABLE TO REPRODUCE THE ISSUE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: D9 (RETURN TO MANUFACTURE DATE).

    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, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BATTERY WILL NOT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565885 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