BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18722839 · Received February 16, 2024

    Report

    Report Number
    2249723-2024-00707
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    February 8, 2024
    Report Date
    November 18, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    CORRECTED FIELDS: D4: A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE BATTERY WAS UNABLE TO SPRING OUT ON ONE SIDE OF THE PUMP. THE FSE REPLACED THE SPRINGS AND POWER SLOT INTERFACE BOARD TO RESOLVE THE ISSUE. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS RETURNED TO CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0670-00-1162 REV. B, SN: (B)(6) SWEMCO, PN: 0997-00-1189 REV. A, SN: (B)(6) SWEMCO PARTS WERE RECEIVED WITH A REPORTED FAILURE OF THE BATTERY GETTING STUCK IN SLOT 1. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND PN: 0997-00-1189 TO HAVE BENT PINS IN SLOT 1. THE FAT INSTALLED PN: 0670-00-1162 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO ISSUES FOUND DURING TESTING. PARTS ARE PHYSICALLY DAMAGED AND OBSOLETE REVISIONS AND WILL NOT BE SENT BACK TO THE SUPPLIER. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    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) HAD A BATTERY THAT WAS STUCK IN SIDE 1. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450822 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 N/A.