Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70

FDA device recall Z-1171-2013 · posted 2013-04-26 · Terminated

Recall details

Recalling firm

Newport Medical Instruments Inc

Reason for recall

Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

Action taken

Newport Medical Instruments sent an Urgent Medical Device Recall letter dated April 4, 2013, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who sold the affected product to another party, or placed the affected product with a patient or healthcare provider were instructed to immediately inform the other party, patient, or healthcare provider of this action and provide them with a copy of the letter. If customers were using the affected product, they should ensure that an alternate source of power is available nearby. Customers were instructed to report any issues with Newport" HT70 and HT70 Plus ventilators or Power Pac batteries to the Technical Support group to ensure proper device reporting procedures are followed. Please call 800-451-3111, extension 500, for U.S. customers; and 714-427-5811, extension 500 for international customers and you will be given further instructions). For questions regarding this recall call 714-427-5811, ext 344. A press release was issued by the firm on 04/18/13.

Root cause

Component design/selection

Status

Terminated

Product code

CBK

Quantity affected

2528 ventilators and 1864 power pac batteries

Distribution

Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT,

Date initiated

2013-04-05

Date posted

2013-04-26

Date terminated

2015-03-10

Location

Costa Mesa, CA

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