Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software version 1.10 pre-installed; Catalog number 2M86300.
This recall has been terminated (originally issued October 27, 2008).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- October 3, 2008
- Posted
- October 27, 2008
- Terminated
- October 16, 2009
- Recall Number
- Z-0202-2009
- Quantity
- 50 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
May experience an interruption of ventilation for approximately 5 seconds
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.
Lot / Code Info
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.
Root Cause
Software design
Action Taken
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.