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WHAT IS THIS?
A Urgent Field Safety Notice is communication sent by a manufacturer to users or customers in relation to a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
EVENT
| Type of Event | Urgent Field Safety Notice |
|---|---|
| Notice Reference | FA1380 |
| Notice Qty | Not Stated |
| Notice Date | June 2024 |
| Notice Link | Link |
| Notes/Details | 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. |
| Reason | Any single PB500 series ventilator should only be used for the 10-year labelled service life. If a patient requires ventilatory support for a longer period of time, cumulative sequential use of more than one PB500 series ventilator should be limited to 14 years. After 14 years of cumulative use, patients should be transitioned to an alternate device. |
DEVICE
| Manufacturer | Medtronic |
|---|---|
| Model Names | 500 Series Ventilators |
| Model Numbers | PB560, PB540, PB520 |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | Ventilator |
| Serial Number(s) | Not stated. |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
Please complete and return the enclosed Customer Acknowledgement Form in the Notice as directed to confirm the receipt and understanding of this information.
• Please provide this notice to those who need to be aware within your organization or to any organization or person where the product has been transferred or distributed.
• Any single PB500 series ventilator should only be used for the 10-year labelled service life. If a patient requires ventilatory support for a longer period of time, cumulative sequential use of more than one PB500 series ventilator should be limited to 14 years. After 14 years of cumulative use, patients should be transitioned to an alternate device.
• When approaching 14 years of cumulative use of a PB500 series ventilator, it is recommended that patients or their caregivers discuss transitioning to an alternate ventilator with the prescribing physician.
CONTACT INFORMATION
If you have any questions regarding this notification, please contact your Medtronic sales representative.
PLEASE EMAIL OR FAX THIS ACKNOWLEDGEMENT TO:
nahar.s.alsurayi@medtronic.com