BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR A3600

    MDR report key: 16144561 · Received January 12, 2023

    Report

    Report Number
    3010825766-2023-00001
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    September 26, 2022
    Report Date
    January 12, 2023
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172341001
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSE WAS WORKING ON THE STORAGE AND RETRIEVAL MODULE (SRM) TO PERFORM A SHELF ADJUSTMENT. IT WAS NOT COMMUNICATED WHICH PROCEDURE AMONG THE ONES REPORTED IN THE SERVICE MANUAL HE WAS FOLLOWING. REVIEWING THE SERVICE MANUAL PROVIDED BY INPECO THE PROCEDURES WHICH REQUIRE THE REMOVAL AND THE LIFT OF THE SRM SIDE COVER INCLUDE THE WARNING: "AT LEAST ONE PERSON ON EACH SIDE OF EACH PANEL IS REQUIRED TO LIFT UP THE PANELS. USE OF PROTECTION GLOVES DURING THIS OPERATION IS MANDATORY." THE FSE REPORTED THAT HE PERFORMED THE OPERATION ALONE. THE SERVICE MANUAL HAS BEEN EVALUATED COMPLETE AND CORRECT. NO FURTHER DETAILS ABOUT THE FSE INJURY AND THE MEDICAL TREATMENT WERE PROVIDED FROM THE FIELD.

    Description of Event or Problem · 0

    THE DISTRIBUTOR REPORTED A FIELD SERVICE ENGINEER SUFFERED A INJURY ON (B)(6) 2022 WHILE HE WAS WORKING ON THE STORAGE AND RETRIEVAL MODULE. HE HURT HIS LEFT SHOULDER WHILE HE WAS REMOVING AND LIFTING THE SRM SIDE COVER TO GAIN ACCESS TO THE SHELVES. THE DOCTOR ORDERED REHAB FROM ON (B)(6) 2022 TO ON (B)(6) 2022. THE FSE DISCONTINUED REHAB ON (B)(6) 2022 AND PERFORMED A MRI ON (B)(6) 2022. THE EVALUATION SHOWS A COMPLETE TEAR OFF OF TENDONS AND LARGE ROTATOR CUFF TEAR. THE FSE IS EVALUATING POSSIBLE TREATMENT OPTIONS SUGGESTED BY HIS DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536006 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA ACP 07640172341001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other