| Class 2 Device Recall Newport HT50 Ventilator | |
Date Initiated by Firm | July 22, 2009 |
Date Posted | May 27, 2011 |
Recall Status1 |
Terminated 3 on June 01, 2011 |
Recall Number | Z-2384-2011 |
Recall Event ID |
58632 |
510(K)Number | K082724 |
Product Classification |
ventilator, continuous, facility use - Product Code CBK
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Product | 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 (22Ibs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications. |
Code Information |
NA |
Recalling Firm/ Manufacturer |
Newport Medical Instruments Inc 1620 Sunflower Ave Costa Mesa CA 92626-1513
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For Additional Information Contact | 714-427-5811 Ext. 344 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 the fuse replacement. Customers with any questions about this fuse replacement or require additional upgrade kits, were instructed to contact Newport Medical's Technical Support Department at (800) 451-3111 or (714) 427-5811 x500. |
Quantity in Commerce | 11, 333 units total |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CBK
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