Newport HT50 Ventilator…

Date posted by the FDA

May 26, 2011

Status

Terminated

Filed by

Newport Medical Instruments Inc

Product

Newport HT50 Ventilator. Model #HT50 H1-B 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), who require the following general types of ventilatory support.

Reason

The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.

Distribution pattern

Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.

Codes and lots

Device Listing Number: D0004206 Serial Numbers: N08HT501212491 through N08HT501212523

Recall started

Jan. 13, 2009

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Other

What the company told customers

Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427-0489. If you have any further questions, please call (714) 427-5811 x 344

Recall number

Z-2295-2011

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

Source: FDA · Medical device enforcement report, recall number Z-2295-2011. The agency record governs; check it and the company before acting.