Recall Z-1153-2020 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Respironics California, LLC
Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461
| Date | Sep 11, 2019 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Other |
| Action | 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 p |
| Quantity | 56 |
| Distribution | US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Em |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc., Jan 9, 2009 |