BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22157511 · Received June 6, 2025

    Report

    Report Number
    2249723-2025-0002504
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 7, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: B5, H6 (INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1, G3, G6, H2, H3, H6 (COMPONENT CODE, INVESTIGATION FINDINGS , INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11. CORRECTED FIELDS: B5. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. HE STATES, GROUND PRONG MISSING FROM LINE CORD. REPLACED LINE CORD ASSEMBLY (0012-00-1688-21) . DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. DEVICE WAS GIVEN TO CUSTOMER AND CLEARED FOR CUSTOMER USE. THE FOLLOWING WAS PERFORMED BY TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT WAYNE, NJ: THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0012-00-1688-21 REV Q; SN: (B)(6) AMETEK REEL, AC POWER CORD THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF GROUND PIN MISSING. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND VERIFIED THE FAILURE MESSAGE OF GROUND PIN WAS MISSING. PLEASE SEE ATTACHED PICTURE. RETAINING REEL, AC POWER CORD IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD POWER CORD ISSUE. GROUND PRONG ON END OF LINE CORD BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD POWER CORD ISSUE. GROUND PLUG ON END OF LINE CORD BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD POWER CORD ISSUE. GROUND PLUG ON END OF LINE CORD BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551673 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