BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 20448961 · Received October 15, 2024

    Report

    Report Number
    2517506-2024-00272
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 15, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414949581
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT WHILE TROUBLESHOOTING THE ALIQUOT PROBE ISSUE, THE SIEMENS CUSTOMER SERVICE ENGINEER'S (CSE) RIB WAS SORE WHILE LEANING IN THE BACK OF THE DIMENSION VISTA 500 INSTRUMENT. THE CSE USED AN ICE PACK AND DID NOT SEEK ANY FURTHER FIRST AID OR MEDICAL INTERVENTION. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THE VISIT, THE CSE INSPECTED THE INSTRUMENT AND NOTED THAT THE CONTROLLER AREA NETWORK (CAN) BOARDS 21 AND 22 WERE SWEATING. THE CSE PUT TOGETHER AN ELEVATOR USING BOTH ASSEMBLIES, REPLACED THE ALIQUOT PLATE ASSEMBLY, VERTICAL SLIDE OF THE PROBE ASSEMBLY, A MOTOR, AND A POSITIONER ASSEMBLY, SWAPPED CANS, FAILED AT STEP COUNTS 12K, AND MOVED THE ALIQUOT (ALQ) ELEVATOR TO THE 12 AND 13K STEPPING POSITIONS AND NOTED MOTION MISMATCHING ERRORS. THE CSE MANIPULATED THE ALQ ELEVATOR ASSEMBLY TO VARYING POSITIONS AND STARTED WORKING. THE CSE RAN A QUICK CHECK AND QUALITY CONTROL (QC), WHICH RECOVERED ACCEPTABLY. SIEMENS EVALUATED THE EVENT AND DETERMINED THAT THE FAULTY ALIQUOT POSITIONER ASSEMBLY AND MOTOR, WHICH WERE RESOLVED BY REPLACING THE VERTICAL SLIDES, MOTOR, AND POSITIONER, POTENTIALLY CONTRIBUTED TO THE ALIQUOT PROBE ISSUE, AND THE UNINTENDED USE ERROR CONTRIBUTED TO THE SORE RIB OF THE CSE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHILE TROUBLESHOOTING THE ALIQUOT PROBE ISSUE, THE SIEMENS CUSTOMER SERVICE ENGINEER'S (CSE) RIB WAS SORE WHILE LEANING IN THE BACK OF THE DIMENSION VISTA 500 INSTRUMENT. THE CSE USED AN ICE PACK AND DID NOT SEEK ANY FURTHER FIRST AID OR MEDICAL INTERVENTION. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32601 DIMENSION VISTA 500 DIMENSION VISTA 500 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500 00630414949581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown