BEUDAMED
    FDA Recall Open, Classified

    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

    Recall: Z-1376-2023 · Initiated January 3, 2023

    Recall

    Recall Number
    Z-1376-2023
    Event Number
    91561
    Firm
    Western/Scott Fetzer Company
    FEI Number
    1526809
    Product Code
    CAN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 3, 2023
    Posted
    April 12, 2023
    Address
    875 Bassett Rd, Westlake, OH, 44145-1142

    Description

    Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size cylinder) MNDS-603, Western Oxytote DTE Digital VIPR System (with E-size cylinder)

    Reason

    Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use without audible alarms, potentially leading to an out of oxygen event and no flow.

    Action

    On January 3, 2023, the firm issued a Safety Alert to customers. Customers were provided with updated operating instructions. Customers instructed to take the following immediate actions: 1. Implement updated filling and venting instructions which include steps for the filler to verify proper gauge pressure after vent down and after fill/re-fill. 2. Implement an additional verification of gauge pressure upon delivery at the healthcare facility. 3. Take care to minimize any impact to the cylinder during use, transportation, or processing during fill/re-fill. The firm continues to evaluate the gauge error issue and will implement additional corrective actions as appropriate.

    Distribution

    US Nationwide distribution in the states of CO, CT, ID, MD, MT, TN, WA.

    Quantity

    24,287 units