Recall Z-1617-2010 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport e360 Ventilator The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type
| Date | May 19, 2010 (initiated Apr 14, 2010) |
| Status | Terminated |
| Reason | The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on Printed Circuit Board (PCB) 2104A in the Newport e360 ventilator. Ventilators manufactured between September and December 2009 are affected by this field correction. All affected ventilators require the replacement of the PCB2104A board to avoid early failure of t |
| Root cause | Other |
| Action | The firm, Newport Medical, sent a "Field Correction Notice" dated April 14, 2010, to all customers. The notice describes the product, problem and actions to be taken by the customers. The customers were instructed to: 1) provide your affected customers with a copy of this letter and advise them to pay close attention to pressure errors which can be an early warning sign of the pressure transducer failure; 2) Schedule their ventilators for replacement of the PCB2104A board as quickly as possible to avoid any unanticipated disruption in their use of their product; 3) Contact our Technical |
| Quantity | 990 |
| Distribution | Worldwide distribution: USA including states of CA, KY, NM, NY, UT and internationally to: Armenia, Bolivia, Brazil, Bulgaria, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Malaysia, Mauritius, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Russia, Saudi Arabi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053502 | NEWPORT E360 VENTILATOR Newport Medical Instruments, Inc., Jan 10, 2006 |