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Recall Observatory FDA recall evidence

Device product

Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.

Z-0692-2016

December 22, 2015

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 72914
Status
Terminated
Classification
Class I
Quantity
402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus)
Official record key
device-enforcement:Z-0692-2016

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 3000 Ventilators and Oxylog 3000 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.