BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNS-350 COMPONENT NEUROMONITORING SYSTEM

    MDR report key: 16245279 · Received January 26, 2023

    Report

    Report Number
    3007880955-2023-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    December 29, 2022
    Report Date
    March 15, 2023
    Manufacturer
    MOBERG RESEARCH, INC.
    Product Code
    GWQ
    UDI-DI
    B485CNS3501
    PMA / PMN Number
    K080217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT THE CUSTOMER REPORTED BATTERY LEAKAGE/CORROSION OF SOME SORT ON THE UNDERSIDE OF THE BATTERY AROUND THE BATTERY CONNECTOR. THE BATTERY IS INSIDE THE CNS-350 COMPONENT NEUROMONITORING SYSTEM. THE CUSTOMER PROVIDED PICTURES OF THESE BATTERIES. MOBERG HAS STARTED AN INVESTIGATION WITH THE MANUFACTURER OF THE BATTERY. FURTHER INVESTIGATION TO BE CARRIED OUT TO DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    MARCH 15, 2023 FOLLOW UP REPORT 001. A REMOVAL / CORRECTION IN RELATION TO THIS ISSUE HAS BEEN INITIATED. OUR INITIAL REPORT 3007880955-02/18/2023-001-R WAS ACKNOWLEDGED AND OUR ACTIONS HAVE BEEN ASSIGNED TO RES# 91782. MOBERG RESEARCH, INC. CAPA REPORT NUMBER: US-CAPA-22-08 DETAILS THE BELOW: VARIOUS CONTAINMENT ACTIONS HAVE BEEN UNDERTAKEN: 1) ADVISORY NOTICE SENT TO ALL CNS-350 CUSTOMERS INSTRUCTING THEM TO REMOVE THE BATTERIES AND SET ASIDE IN A SAFE LOCATION UNTIL FURTHER NOTICE. (CUSTOMERS MAY CONTINUE TO USE THE CNS-350 UNDER NORMAL OPERATING CONDITIONS.) MOBERG RESEARCH, INC. IS TRACKING ALL CNS-350 CUSTOMERS TO CONFIRM THAT THE BATTERIES HAVE BEEN REMOVED. 2) ALL PRODUCTION CNS-350 SYSTEMS ARE BEING SHIPPED WITHOUT THE BATTERY INCLUDED. MOBERG IS STORING ALL BATTERIES IN A SAFE LOCATION IN-HOUSE. 3) ALL SERVICED CNS-350 SYSTEMS ARE HAVING THE BATTERY REMOVED AND STORED IN A SAFE PLACE IN-HOUSE. IDENTIFIED ROOT CAUSE(S): 1) MOBERG RESEARCH, INC. FAILED TO PROPERLY EVALUATE WHETHER THE BATTERIES CHOSEN TO BE USED IN THE CNS-350 WERE DESIGNED AND TESTED FOR OUR PARTICULAR USE CASE. 2) MOBERG RESEARCH, INC.I FAILED TO INCLUDE IN ITS HAZARD ANALYSIS/RISK ASSESSMENT PLAN/WHATEVER THE POSSIBILITY OF CATASTROPHIC BATTERY FAILURE (SUCH AS LEAKAGE). THESE ONLY COVER RISKS ASSOCIATED WITH THE BATTERY CEASING TO FUNCTION. CORRECTIONS: 1) BATTERIES WITH THE OLDER FIRMWARE WILL NO LONGER BE USED FOR PRODUCTION OR REPAIR OF CNS-350 SYSTEMS. ANY BATTERIES USED IN WIP, STOCK, OR ON-ORDER ITEMS WILL BE ISOLATED FROM PRODUCTION AND SERVICE AREAS TO PREVENT ACCIDENTAL USE. THESE MAY BE DESTROYED OR RETURNED TO THE SUPPLIER AT THE DISCRETION OF MGMT. 2) BATTERIES WITH NEW FIRMWARE WILL BE PURCHASED AND LABELED WITH THE FIRMWARE INFORMATION. SERIAL NUMBERS AND FIRMWARE INFO WILL BE TRACKED AS PART OF THE DEVICE HISTORY RECORD. SINCE THERE IS NO WAY TO DETERMINE WHETHER EXISTING CUSTOMERS HAVE THE OLD OR NEW FIRMWARE, ALL EXISTING CUSTOMERS' BATTERIES WILL BE REPLACED. 3) NEW BATTERIES WILL BE TESTED/PREPARED BY DISCHARGING/RECHARGING ACCORDING TO SUPPLIER'S IFU BEFORE SHIPPING TO CUSTOMER OR SERVICING UNITS. PROCEDURE(S) WILL BE CREATED/MODIFIED TO REFLECT THE PROCESS CHANGE. 4) SEND FIELD SAFETY NOTICE (FSN) LETTER TO CUSTOMERS/DISTRIBUTORS INSTRUCTING THEM TO REMOVE THE BATTERY FROM EACH SYSTEM (IF THEY HAVE NOT YET DONE SO). THEY WILL BE INSTRUCTED TO USE LATEX GLOVES OR OTHER BASIC PROTECTION TO AVOID CONTACT WITH ANY LEAKED BATTERY FLUID. THEY WILL BE ASKED TO DISPOSE OF OR DESTROY THE BATTERY ACCORDING TO EACH INSTITUTION'S POLICIES. THEY WILL THEN BE INSTRUCTED TO INSERT THE NEW BATTERY PROVIDED BY MOBERG RESEARCH, INC. THEY WILL BE ASKED TO CONFIRM WITH MOBERG RESEARCH, INC. THAT THESE STEPS HAVE BEEN TAKEN. CORRECTIVE ACTIONS: 1) HAZARD ANALYSIS/RISK MANAGEMENT FILE WILL BE UPDATED TO INCLUDE RISK ASSOCIATED WITH BATTERY LEAKAGE OR OTHER CATASTROPHIC FAILURE. TO BE REVIEWED AND APPROVED BY ENGINEERING (DOCUMENTED). 2) ANY FUTURE PRODUCT DESIGN OR CHANGE TO EXISTING PRODUCT DESIGN TO INCLUDE DOCUMENTED EVALUATION OF BATTERY AS IT APPLIES TO OUR PARTICULAR USE CASE. TARGET DATE FOR IMPLEMENTATION: APRIL 30, 2023.

    Description of Event or Problem · 0

    MOBERG RESEARCH, INC. HAS BECOME AWARE OF A COMPLAINT OF THE BACKUP BATTERY INSIDE TWO CNS-350 PRODUCTS WERE LEAKING. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    MOBERG RESEARCH, INC. HAS BECOME AWARE OF A COMPLAINT OF THE BACKUP BATTERY INSIDE TWO CNS-350 PRODUCTS WERE LEAKING. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381405 CNS-350 COMPONENT NEUROMONITORING SYSTEM CNS-350 COMPONENT NEUROMONITORING SYSTEM GWQ MOBERG RESEARCH, INC. CNS-350 B485CNS3501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown