Recall Z-2384-2011 ยท CBK Ventilator, Continuous, Facility Use
Newport Medical Instruments Inc
Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code: NOU The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22Ib
| Date | May 27, 2011 (initiated Jul 22, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because Newport Medical has confirmed that the HT50 Dual Pac Ventilator is not compatiable with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. The Dual Pac system has a slightly higher amperage draw than the single battery and as a result can cause the fuse in the external battery pack to blow making the battery inoperable. |
| Root cause | Other |
| Action | Newport Medical sent an IMPORTANT PRODUCT NOTICE on July 22, 2009, to all affected customers who purchased the Newport HT50 Dual Pac Ventilator with the external battery pack (p/n BAT3300A) supplied with the previous single battery ventilator. Newport Medical also sent an upgrade kit (FSK3301) which includes instructions for changing the fuse on the external battery. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to not use an external battery with the new Dual Pac Ventilator until they have completed th |
| Quantity | 11, 333 units total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM Newport Medical Instruments, Inc., Dec 16, 2008 |