BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18545132 · Received January 19, 2024

    Report

    Report Number
    2249723-2024-00272
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    January 12, 2024
    Report Date
    December 19, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL FIELDS: E1 (EVENT SITE ADDRESS: 2-1312, EVENT SITE ADDRESS LINE 2: (B)(6), EVENT SITE STATE: (B)(6), EVENT SITE POSTAL CODE: (B)(6)). IT WAS REPORTED THAT DURING INSPECTION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD FAULT 63 AND DATE AND TIME MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) RESOLVED THE ISSUE BY REPLACING THE TOUCHSCREEN D160-00-0123 AND EXEC PROCESSOR D670-00-0770 . FSE CALIBRATED AND THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE.THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FOLLOWING INVESTIGATION WAS PERFORMED BY ANGEL RODRIGUEZ, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 16 JULY 2024. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0160-00-0123 AND PART NUMBER 0670-00-0770 REV. C, SN 12 00406 06-NBS WITH A REPORTED UNIT FAILURE A FAULT 63 AND A DATE AND TIME MALFUNCTION. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION.THE FAT INSTALLED PART NUMBER 0160-00-0123 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. THE FAT INSTALLED AND PART NUMBER 0670-00-0770 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. CONFIRMED THE REPORTED FAILURE BUT NO ROOT CAUSE DEFINED. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED. THIS REVISION IS OBSOLETE AND NO LONGER ABLE TO BE TESTED BY A SUPPLIER.RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4)."

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11 CORRECTED FIELDS: E1, EVENT SITE ADDRESS, EVENT SITE ADDRESS LINE 2

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INSPECTION THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) TOUCH PANEL OPERATION FAILURE. 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
    1190925 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