BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16286070 · Received February 2, 2023

    Report

    Report Number
    2249723-2023-00907
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 19, 2023
    Report Date
    January 8, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: CAPITAL HEALTH MED CTR HOPEWELL A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: B4, G3, G6, H2, H10, H11. CORRECTED SECTIONS: B5, E1(NAME, EMAIL), E3.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE ISSUE. THE FSE PERFORMED AN EXTERNAL CHECK AND FOUND DAMAGE TO THE OUTER COVER REAR. THE FSE ALSO OBSERVED THAT THE UNIT WAS NOT CONNECTED TO POWER AND THE BATTERIES DEPLETED. THE FSE CHECKED THE LOGS AND VERIFIED TE 137. THE FSE WAS UNABLE TO VERIFY ANY HELIUM LEAKS. THE FSE THEN FOUND ONE BATTERY NOT CHARGING. IN ORDER TO FIX THAT ISSUE, THE FSE REPLACED THE DISPLAY MONITOR TO VIDEO GEN BOARD KIT AND BATTERY . FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK WERE PERFORMED TO FACTORY SPECIFICATIONS. THE UNIT WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER: 0040-00-0456 (KIT) PN: 0670-00-1182 REV. E, SN: (B)(6), PCBA VIDEO GENERATOR PN: 0012-00-1845 REV. A, SN: (B)(6) PN: 0670-00-1183 REV. C, SN: (B)(6), PCBA UPPER DISPLAY MONITOR THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF A FAULT CODE #137. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED AND TESTED THE MENTIONED PARTS IN CARDIOSAVE TEST FIXTURE TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. FAT WAS UNABLE TO REPLICATE THE REPORTED ISSUE OF THE #137 FAULT CODE. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPT. PER PROCEDURE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER: 0040-00-0456 (KIT) PN: 0670-00-1182 REV. E, SN: (B)(6), PCBA VIDEO GENERATOR PN: 0012-00-1845 REV. A, SN: (B)(6) PN: 0670-00-1183 REV. C, SN: (B)(6), PCBA UPPER DISPLAY MONITOR THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF A FAULT CODE #137. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED AND TESTED THE MENTIONED PARTS IN CARDIOSAVE TEST FIXTURE TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. FAT WAS UNABLE TO REPLICATE THE REPORTED ISSUE OF THE #137 FAULT CODE. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPT. PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS LEAKING HELIUM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INITIAL SETUP, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS LEAKING HELIUM. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381126 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.