BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19905336 · Received August 5, 2024

    Report

    Report Number
    2249723-2024-03139
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 16, 2024
    Report Date
    May 9, 2025
    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

    UPDATED FIELD: B4, D8, D9, (G1(CONTACT OFFICE, CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND WAS ABLE TO CONFIRM THE REPORTED ISSUE. UNIT FAILED TO POWER UP DUE TO SALINE SPILL. SALINE CONTAMINATION TO MOTOR CONTROL, POWER MANAGEMENT AND SOLENOID CONTROL BOARDS. CUSTOMER ABUSE TO PIM. ALL CONTAMINATED MOTOR CONTROL BOARD, POWER MANAGEMENT BOARD AND SOLENOID CONTROL BOARD REPLACED AS WELL AS DAMAGED PIM. UNIT PASSED ALL FUNCTIONALITY AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0997-00-1178 PIM SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1159 MOTOR CONTROL BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1161 SOLENOID CONTROL BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1162 POWER MANAGEMENT BOARD SERIAL NUMBER (B)(6) PART NUMBER 0997-00-1178 PIM SERIAL NUMBER (B)(6) WAS RECEIVED WITH A REPORTED UNIT FAILURE OF THE PIM BEING DAMAGED. PART NUMBER 0670-00-1159 MOTOR CONTROL BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1161 SOLENOID CONTROL BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1162 POWER MANAGEMENT BOARD SERIAL NUMBER (B)(6) WERE RECEIVED WITH A REPORTED UNIT FAILURE OF SALINE DAMAGE ON EACH BOARD. THE FAILURE ANALYSIS AND TESTING DEPT. FIRST PERFORMED A VISUAL INSPECTION ON THE PIM AND FOUND A DAMAGED SECTION ON THE FACEPLATE OF THE PIM. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION OF PART NUMBER 0670-00-1159 MOTOR CONTROL BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1161 SOLENOID CONTROL BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1162 POWER MANAGEMENT BOARD SERIAL NUMBER (B)(6) AND OBSERVED A WHITE RESIDUE ON EACH OF THE THREE BOARDS. THIS WHITE RESIDUE IS CONSISTENT WITH SALINE. PLEASE SEE ATTACHMENT. RETAINING THE PARTS IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV.AR. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, D9, G3, G6, H1, H2.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4,G3,G6,H2,H10,H11. CORRECTED DATA: B5, H6 (PROBLEM CODE).

    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 THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) IS NOT WORKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TRANSPORT OF PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DID NOT POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265829 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