BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18138991 · Received November 15, 2023

    Report

    Report Number
    2249723-2023-04877
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    November 7, 2023
    Report Date
    September 27, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    THE FAT DEPT RECEIVED PART FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING:1. PERFORM VISUAL CHECK RESULT: NO ABNORMALITIES FOUND 2. BOARD WAS RE-TESTED AT FCT RESULT: FAILED STOP 4.9.8 BCP, AC/BULK, (DCIN/BAT) (PATHENABLE) AT TP59. 3. PERFORM TROUBLESHOOTING RESULT: FOUND COMPONENT Q35 DEFECTIVE. Q35 DEFECTIVE. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008 AQ. THE FAT DEPT RECEIVED PART FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING:1. PERFORM VISUAL CHECK RESULT: NO ABNORMALITIES FOUND 2. BOARD WAS RE-TESTED AT FCT RESULT: PASSED RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008.THE FAT DEPT RECEIVED PART FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING:"1. PERFORM VISUAL CHECK RESULT: NO ABNORMALITIES FOUND 2. BOARD WAS RE-TESTED AT FCT RESULT: PASSED. RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008.THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. 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

    FST ARRIVED ON SITE AND VERIFIED POWER UP FAILURE. UNIT PRODUCING SYSTEM FAILURE AUDIBLE ALARM. IABP CONSOLE ALSO POWERS UP BY ITSELF WHEN CONNECTED TO THE HOSPITAL CART AND AC POWER. UNABLE TO ACCESS SERVICE MODE. FRONT END AND EXECUTIVE PROCESSOR PCBA WERE EACH SWAPPED OUT FOR TROUBLESHOOTING PURPOSES. NEITHER RESOLVED THE ISSUE AND ORIGINAL PCBAS WERE REINSTALLED. BACKPLANE PCBA WAS REPLACED. HOWEVER SYSTEM FAILURE BUZZER NOT FUNCTIONING. SYSTEM FAILURE STILL OCCURING HOWEVER FST WAS ABLE TO ACCESS SERVICE MODE LOGS. EVENT LOGS RECORDED MULTIPLE FAULT CODE # 118. IABP NOW BOOTS UP SUCCESSFULLY BUT STILL TURNS OFF BY ITSELF WHEN CONNECTED TO THE CART. FURTHER TROUBLESHOOTING GENERATED FAULT CODE # 139. POWER MANAGEMENT PCBA WAS REPLACED. CART POWER UP ISSUE NOW RESOLVED. FILL MANIFOLD LEAK TEST FAILED DURING FUNCTIONAL TESTING. FILL VALVE DIFF. PRESSURE EXCEEDED THE ACCEPTABLE LEVEL OF ± 12MMHG. HELIUM FILL MANIFOLD ASSEMBLY WAS REPLACED. SOLENOID CONTROL WAS REPLACED COMPLETE PM PERFORMED WITH FULL CALIBRATION. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE FAT DEPT RECEIVED PART NUMBER SERIAL NUMBER: FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: 1. PERFORM VISUAL CHECK. RESULT: NO ABNORMALITIES FOUND. 2. BOARD WAS RE-TESTED AT FCT . RESULT: FAILED STEP S0227 4.3.6 ISOLATION VALVE K4 (LED ON). 3. PERFORM TROUBLESHOOTING. RESULT: FOUND COMPONENT C38 DEFECTIVE. C38 DEFECTIVE. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008. THE FAT DEPT RECEIVED PART NUMBER SERIAL NUMBER:_EDM FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: 1. PERFORM VISUAL CHECK. RESULT: NO ABNORMALITIES FOUND. 2. BOARD WAS RE-TESTED AT FCT. RESULT: FAILED STOP 4.9.8 BCP, AC/BULK, (DCIN/BAT) (PATHENABLE) AT TP59. 3. PERFORM TROUBLESHOOTING. RESULT: FOUND COMPONENT Q35 DEFECTIVE. Q35 DEFECTIVE. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008. THE FAT DEPT RECEIVED PART NUMBER: SERIAL NUMBER:_EDM FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: 1. PERFORM VISUAL CHECK. RESULT: NO ABNORMALITIES FOUND. 2. BOARD WAS RE-TESTED AT FCT RESULT: PASSED. RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008. THE FAT DEPT RECEIVED PART NUMBER: SERIAL NUMBER: FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: "1. PERFORM VISUAL CHECK. RESULT: NO ABNORMALITIES FOUND. 2. BOARD WAS RE-TESTED AT FCT RESULT: PASSED. RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUTS OFF AFTER BOOTING. IT WILL NOT STAY ON. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292964 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