BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20102899 · Received August 29, 2024

    Report

    Report Number
    2249723-2024-03544
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 8, 2024
    Report Date
    March 9, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. A GETINGE FIELD SERVICE ENGINEER REPORTED MONITOR DISPLAY SUSTAINED SUBSTANTIAL DAMAGE TO ITS CASE, REQUIRING REPLACEMENT OF ASSY TOP LEVEL DISPLAY, NEW COILED CORD. DAMAGED HOSPITAL CART REPLACED. REEL, AC POWER CORD, ASSY, TOP LEVEL DISPLAY, REPLACED. NVRAM IC REPLACED. REPAIR, COMPLETE PM, CALIBRATION, FULL FUNCTIONAL TESTS AND SAFETY TESTS AS PER THE SERVICE MANUAL. UNIT PASSED ALL TESTS. THERE ARE NO RECORDS OF SAFETY DISK BEING DAMAGED. IT WAS REPLACED AS PART OF THE REGULAR PM.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, CONCLUSION), H11. CORRECTED FIELD: D8. (B)(6). THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-1179 AND PN 0997-00-1178 WITH A REPORTED UNIT FAILURE OF SHIPPING DAMAGE TO THE HOSPITAL CART. THE PIM WAS REPLACED DUE TO A PM. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND 0997-00-1179 TO HAVE SCRATCHES AND BLEMISHES WHICH ARE CONSISTENT WITH THE REPORTED SHIPPING DAMAGE. PROBABLE CAUSE WILL BE SUPPLY CHAIN - HANDLING DAMAGE. PN 0997-00-1178 WILL NOT BE TESTED DUE TO THIS BEING A PM REPLACEMENT. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AV. A GETINGE FIELD SERVICE ENGINEER STATED THAT THE MONITOR DISPLAY SUSTAINED SUBSTANTIAL DAMAGE TO ITS CASE, REQUIRING REPLACEMENT OF ASSY TOP LEVEL DISPLAY, NEW COILED CORD. FSE REPLACED HOSPITAL CART (D997-00-1179), PNEUMATIC MODULE ASSY (D997-00-1178), AC POWER CORD (D012-00-1688-01), TOP LEVEL DISPLAY (D997-00-1181), NVRAM IC (MCA000000108), SAFETY DISK AND FEW OTHER DISPOSABLE PARTS WAS REPLACED AS A PART OF REGULAR PM. COMPLETED PM, CALIBRATION, FULL FUNCTIONAL TESTS AND SAFETY TESTS AS PER THE SERVICE MANUAL. UNIT PASSED ALL TESTS. COMPLETION OF SERVICE BULLETIN MCA00002038 CARDIOSAVE COILED CORD FIELD SAFETY CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    T WAS REPORTED THAT GETINGE IN-HOUSE LOANER CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) MONITOR WAS DAMAGED DURING SHIPPING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451700 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.