Newport HT50 Ventilator…

Date posted by the FDA

May 26, 2011

Status

Terminated

Filed by

Newport Medical Instruments Inc

Product

Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. 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 (22 Ibs)

Reason

The recall was initiated because Newport Medical has confirmed that the Newport HT50 hard shell Emergency Preparedness (EP) Storage Cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.

Distribution pattern

Worldwide Distribution -- USA including states of PA, TX, AK, GA, CA, MD, KY, FL, VA, LA, NC, OK and countries of Canada, Colombia, Armenia and Japan.

Quantity

1,113 EP cases

Codes and lots

EP Cases are not serialized and are not always associated with a specific ventilator serial number. The field correction applies to all Emergency Preparedness (EP) Storage Cases used to store HT 50 ventilators.

Recall started

May 14, 2010

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Other

What the company told customers

Newport Medical sent an FIELD CORRECTION NOTICE to all affected customers dated May 14, 2010. The letter identified the product, the problem and the action needed to be taken by the customer. Newport Medical also provided a revised labeling for the Emergency Preparedness (EP) Storage Case and an instruction sheet describing where to apply the new labels. Customers were instructed with the information that all the EP storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. Customers were instructed to complete the attached acknowledgement form and fax it to " Regulatory@NewportMedical.com " Customers with any questions should call Technical Support Department at (800) 451-3111 for US customers, and (714)427-5811 x500 for international customers.

Recall number

Z-2382-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2382-2011. The agency record governs; check it and the company before acting.