Device product
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
Z-1992-2023
Product summary
- Event
- Event 92353
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 936 units
- Official record key
device-enforcement:Z-1992-2023
Official wording
Reason: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
Code information: All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001
Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, VT, WA, and WI.
Derived failure modes
-
Unknown
The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.