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 (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.

Recall number

Z-2384-2011

Recalling firm

Newport Medical Instruments Inc

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.

Status

Terminated

Initiated

2009-07-22

Posted

2011-05-27

Terminated

2011-06-01

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 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

11, 333 units total

Distribution

Nationwide Distribution

Lot, serial or model codes

NA

510(k) numbers

["K082724"]

PMA numbers

not on file

Product code

CBK

Firm FEI

2023050

Firm city

Costa Mesa

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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