BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 16472029 · Received March 2, 2023

    Report

    Report Number
    2249723-2023-01363
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 22, 2023
    Report Date
    September 4, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND THAT FIBER OPTIC TESTS FAILED DURING TESTING. FSE RESOLVED THE ISSUE BY REPLACING ASSY,FIBER OPTIC,ROHS. FSE THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED ASSEMBLY FIBER OPTIC, WITH A REPORTED UNIT FAILURE OF A FAILED FIBER OPTIC TEST. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION.THE FAT INSTALLED ASSY,FIBER OPTIC,ROHS INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. PERFORMED A FIBER OPTIC FUNCTIONAL TEST AND FAILED. THE FAT VERIFIED THE REPORTED ISSUE OF A FAILED FIBER OPTIC TEST. SENDING THE BOARD TO THE RESPECTIVE SUPPLIER PER PROCEDURE NUMBER 0002-07-D008 REV. AP. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AP. THE FAT DEPT RECEIVED ASSY,FIBER OPTIC,ROHS FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: PERFORMED VISUAL CHECK AND NO ABNORMALITIES FOUND. BOARD WAS RE-TESTED AT FCT AND PASSED. RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FIBER OPTIC FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516811 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-52 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown