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U.S. Department of Health and Human Services

Class 2 Device Recall Oxylog 3000

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 Class 2 Recall
Oxylog 3000
see related information
Date Posted October 27, 2008
Recall Status1 Terminated on October 16, 2009
Recall Number Z-0202-2009
Recall Event ID 49578
Premarket Notification
510(K) Number
K062267 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
Code Information Serial numbers SRZA-0182 and higher tahn 0182, SRZB-xxxx, SRZC-xxxx, SRZD-xxxx, SRZE-xxxx, SRZF-xxxx, SRZH-xxxx, and SRZJ-xxxx. Note that xxxx stands for numbers 0001 through 9999.
Recalling Firm/
Manufacturer
Draeger Medical, Inc.
3135 Quarry Rd
Telford, Pennsylvania 18969-1042
For Additional Information Contact Technical Support
800-543-5047
Manufacturer Reason
for Recall
May experience an interruption of ventilation for approximately 5 seconds
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm issued an Urgent - Medical Device Recall letter dated September 2008. Software version 1.10 may under specific conditions experience an interruption of ventilation for approximately 5 seconds. During that time period, the patient airway pressure may drop to zero. This phenomenon was identified by Draeger engineers and to date has not been reported by any user. The firm's investigations revealed that when ventilating in BIPAP mode with the pressure rise time (Ramp) set to the highest setting and the expiration time set to exactly 0.5 seconds, the inspiration phase can coincide with the internal auto zero function of the device. Under these circumstances a pressure spike will occur upon reaching Pmax +5mbar (cmH2O) which with software version 1.10 will lead to the inspiratory phase stopping. Ventilation will resume after approximately 5 seconds. The device will generate a Paw Measurement INOP alarm. Until the new software is available, customers are being instructed to avoid the use of the following combination of settings: 1) BIPAP mode; 2) Ramp = highest, and 3) Texp = 0.5 seconds.
Quantity in Commerce 50 units
Distribution Nationwide Distribution --- including states of AZ, CA, FL, IL, IN, KY, LA, ME, MI, MO, NC, NE, NJ, NY, OH, PA, TX, UT, VT, WA, WV, and WY.
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 = DRAGER MEDICAL B.V.
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