• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Newport HT50 Ventilator

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Newport HT50 Ventilator
see related information
Date Posted May 27, 2011
Recall Status1 Terminated on June 01, 2011
Recall Number Z-2384-2011
Recall Event ID 58632
Premarket Notification
510(K) Number
K082724 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
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, California 92626-1513
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/UNDETERMINED: Pending
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.
-
-