BEUDAMED
    FDA Recall Open, Classified

    Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840

    Recall: Z-0267-2022 · Initiated October 16, 2021

    Recall

    Recall Number
    Z-0267-2022
    Event Number
    88877
    Firm
    Western/Scott Fetzer Company
    FEI Number
    1526809
    Product Code
    ECX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 16, 2021
    Address
    875 Bassett Rd, Westlake, OH, 44145-1142

    Description

    Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840

    Reason

    VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke

    Action

    Western / Scott Fetzer Co. issued Urgent Medical device Recall letter, dated 10/15/21 distributed via USPS to consignees on 10/16/21, and emailed to the same consignees on 10/18/21. Letter states reason for recall , health risk and action to take: Fill facility employees are asked to verify the functionality of each unit through the observation of information on the digital display. Note that this direction and expectation is already clearly indicated in the product Operating Instructions and Inspection Guidelines. If the digital display shows the expected information as depicted in the Operating Instructions and Inspection Guidelines, the unit is functioning properly and may remain in use. If the digital display is blank, the unit is to be isolated and returned to Western for inspection. As a longer term solution, beginning in October 2021, product within the scope of the recall is to be corrected as follows: 1. For Digital VIPR products that do not include a cylinder (MNDR-600), units will be returned to Western via RGA to perform the following services: " Remove shroud from unit to determine battery type used " If 3500mAh battery found, replace it with 4000mAh battery " If 4000mAh battery found, inspect for battery lead wire damage, replace if damage found " Remove potential burr / sharp edge from screw boss on regulator body " Replace back shroud with modified back shroud (pinch points removed) " Reassemble unit per revised assembly procedure " Apply new control knob sticker (green logo, silver background) Page 3 of 6 2. For Digital products that include a cylinder (ROC-9840 and MNDS-602), Western employees will visit customer fill facility locations to perform the following services: " Remove shroud from unit to determine battery type used " If 3500mAh battery found, replace it with 4000mAh battery " If 4000mAh battery found, inspect for battery lead wire damage, replace if damage found " Remove potential burr / sharp edge from screw boss on regulator body " Re

    Distribution

    CT, MD, MT, OH

    Quantity

    11341 units