BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19072813 · Received April 9, 2024

    Report

    Report Number
    2249723-2024-01474
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 29, 2024
    Report Date
    August 29, 2025
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED IN ORDER TO EVALUATE THE UNIT AND IT WAS FOUND THAT THE BAY 2 WAS SHOWING BAD BATTERY. BUT AFTER THE SWAPPING OF BATTERIES IT WAS BEING SHOWED THAT THE ISSUE WAS IN BAY 2 AND NOT THE BATTERY. FSE HAD FURTHER REPLACED THE (D670-00-1162) PCBA, POWER MANAGEMENT BOARD WHICH HAD CORRECTED THIS ISSUE. THE UNIT HAD PASSED ALL THE CALIBRATION, FUNCTIONAL AND SAFETY TESTS HAD BEEN PERFORMED. THE UNIT WAS RETURNED TO THE CUSTOMER AND CLEARED FOR THE CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT ROHS, SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF BATTERY BAY 2 WAS SHOWING A BAD BATTERY. SWAPPING THE BATTERY SHOWED THAT THE ISSUE WAS IN BAY 2 AND NOT THE BATTERY. 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 0670-00-1162 PCB, POWER MANAGEMENT ROHS, SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT INSTALLED A BATTERY INTO BATTERY BAY 2. THE BATTERY PROCEEDED TO CHARGE WHEN THE CONSOLE WAS INSTALLED INTO THE CARDIOSAVE CART, WITH THE CART PLUGGED INTO AC. THE FAT DEPT. THEN PROCEEDED TO UNPLUG THE CART FROM AC AND ALLOW THE CARDIOSAVE TO RUN ON BATTERY. THE BATTERY PERFORMED TO FACTORY SPECIFICATIONS IN BATTERY BAY 2. THE FAT DEPT. COULD NOT VERIFY AN ISSUE WITH BATTERY BAY 2. THE FAT DEPT. COULD NOT VERIFY THE COMPLAINT OF A SPONTANEOUS SHUT DOWN. THE POWER MANAGEMENT BOARD PASSED TESTING. SENDING THE POWER MANAGEMENT BOARD TO THE SUPPLIER PER PROCEDURE NUMBER 0002-07-D008 REV.AR. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PART. PLEASE SEE ATTACHMENT. THEY STATED: BOARD WAS RE-TESTED AT FCT RESULT: FAILED STEP 4.12.2.1 VOLTAGE LOOP VERIFICATION SLOT2 3. PERFORM TROUBLESHOOTING ON THE BOARD: FOUND U6 DEFECTIVE: PROBABLE ROOT CAUSE FOR THIS PART IS A MANUFACTURING ASSEMBLY ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AR. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING ASSEMBLY.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, G1, G3, G6, H2, H11. CORRECTED FIELDS: D8, E3, H6 (INVESTIGATION CONCLUSION).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT BY THE CUSTOMER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SPONTANEOUS SHUT DOWN. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238078 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male