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Recall Observatory FDA recall evidence

Device product

Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.

Z-0691-2016

December 22, 2015

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 72914
Status
Terminated
Classification
Class I
Quantity
0
Official record key
device-enforcement:Z-0691-2016

Official wording

Reason: Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.

Code information: All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.

Distribution pattern: Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.