BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECHRIST INDUSTRIES INC. E-GURNEY

    MDR report key: 16504229 · Received March 8, 2023

    Report

    Report Number
    2020676-2023-00004
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 24, 2023
    Report Date
    March 8, 2023
    Manufacturer
    SECHRIST INDUSTRIES INC.
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT WAS REPORTED BY A SECHRIST INDUSTRIES INC. SALES REPRESENTATIVE ON BEHALF OF THE CUSTOMER. NO PATIENT INCIDENT WAS REPORTED. EVALUATION OF THE BATTERY PACK IS NOT POSSIBLE AS THE UNIT WILL NOT BE RETURNED TO SECHRIST FOR EVALUATION. SINCE THE UNIT WILL NOT BE RETURNED, WE CANNOT CONFIRM THE REPORTED ISSUE OR CONDUCT AN INVESTIGATION ON THE UNIT. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENTON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASESSED,DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE NO. (B)(4).

    Description of Event or Problem · 0

    CUSTOMER IS REPORTING THAT THE BATTERY PLUG TAB THAT HOLD THE CONNECTOR IN MALE CONFIGURATION IS BROKEN AND ALLOWS IT TO SLIDE EXPOSING THE CONTACT POINT. CUSTOMER PLUGGED IN THE BATTERY TO THE CHARGER IN THE WRONG CONFIGURATION CASUING THE BATTERY TO SHORT AND SPARK. NO PATIENT INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163438 SECHRIST INDUSTRIES INC. E-GURNEY ELECTRONIC GURNEY FPO SECHRIST INDUSTRIES INC. 20582-101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown