Respironics California, LLC Respironics V680 Ventilator, Service # 850011, (OUS Only) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

Recommended Action

Per FDA guidance

On 09/26/19, Urgent Medical Device Correction Field Safety Notices were mailed to customers. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Ventilator): 1) If in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If a touchscreen failure is detected, disconnect the patient and immediately start ventilation with an alternate device. Contact your local customer service representative to report the failure. 3) To minimize the risk of patient injury, operate the Ventilator as defined in the operator's manual and promptly attend to all alarms presented by the ventilator. 4) As recommended in the operator's manual, use an external 02 monitor/analyzer and set the alarm thresholds appropriately. 5) As recommended in the operator's manual, have an alternative means of ventilation available whenever the ventilator is in use. 6) Acknowledge receipt of this notification. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (User Interface RP-Kits): 1) If the affected kit is installed on a ventilator and in use on a patient, continue to use the ventilator if an alternative non-invasive ventilator is not available. 2) If the affected kit is installed on a ventilator, document the serial number of the ventilator and the serial number of the affected User Interface Assembly it contained, on the attached Acknowledgement and Receipt Form. 3) If the affected devices could not be found or linked to a ventilator at your site, please indicate this within in the detail section provided on the form, 4) Return the completed and signed Acknowledgement and Receipt Form. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction notification/Field Safety Notice (Tou