Puritan Bennett 560 Ventilator

Standard toxicological test methods were employed to characterize the risk of exposure to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro, released from some components in the gas pathway of the device. Manufacturer determined that the device is safe for both intermittent and continuous use, for invasive and non-invasive ventilation for both pediatric and adult patients, over the entire duration of the labeled service life (10 years) and are in compliance with international published standards. For patients that require ventilation therapy beyond the full duration of the device's service life, a second unit may be required to allow the patient to continue receiving ventilation therapy beyond the initial 10 years. Additional test analyses suggest that cumulative use of over 14 years may potentially pose a harm to health. These conclusions are derived from chemical testing and risk assessment from literature, including animal laboratory testing. There are no conclusive human clinical data describing quantifiable risk. No customer complaints have been received reporting any of these potential harms. There are no anticipated harms associated with exposure to the identified chemical so long as the cumulative use of these devices does not exceed 14 years. Toxicological assessment based on small animal laboratory testing suggests that, with greater than 14 cumulative years of use of the device, exposure to the identified chemical has a maximum potential risk of 1 in 10,000 for cancer, birth defects/deformity, infertility, or abnormal fetal development.

Continued, sequential, use of device is appropriate for patients who currently are using the devices for invasive and non-invasive ventilation therapy for up to and including 14 years of cumulative use. Any single device should only be used for the 10-year labelled service life, but if ventilatory support is required for a longer period using more than one device over time, the use of these devices for more than 14 years of cumulative duration is not advised. It is recommended that caregivers of patients approaching 14 years of cumulative use of device discuss changing their ventilatory support to an alternate ventilator with the patient's prescribing physician.

Recall start date: June 27, 2024