Class 2 Device Recall Drger Softbed Resuscitaire with Scale

• Date Initiated by Firm: May 16, 2023
• Date Posted: June 22, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1992-2023
• Recall Event ID: 92353
• 510(K)Number: K120642
• Product Classification: Warmer, infant radiant - Product Code FMT
• 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]
• Code Information: All units shipped from January 20, 2020 through March 1, 2023; MU20503 (Resuscitaire) UDI - 04049098000215 MU20512 (Birthing Room Warmer - BRW) UDI - 04049098058001
• FEI Number: 2510954
• Recalling Firm/ Manufacturer: Draeger Medical Systems, Inc.; 3135 Quarry Rd; Telford PA 18969-1042
• For Additional Information Contact: Mike Kelhart; 267-664-1131
• Manufacturer Reason for Recall: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
• FDA Determined Cause: Device Design
• Action: An Urgent - Medical Device Correction dated May 2023 was sent to customers. Actions to be taken: Please ensure that all users of the above-mentioned products and other persons within your organization are made aware of this Important Safety Notice. If you have provided the products to third parties, please forward a copy of this information. Users can mitigate this risk by performing the visual check, test procedure and take appropriate actions based on the Attachment provided in this notice. Complete and return the enclosed Customer Acknowledgement and Response Form . We are continuing to evaluate this issue and will advise the affected customers when we have an alternative solution. Visual Check for Correct Mattress Placement: To ensure proper operation of the scale, please check to confirm there is a clearance between the mattress cover and the corner blocks and side panels of the Resuscitaire. 1. Ensure mattress with cover is installed in the Resuscitaire bassinet. 2. Observe edges of mattress for clearance with corner blocks and side panels, see Figure 2. 3. If there is interference, then the scale may not provide accurate weight measurements. It is recommended to use an independent scale for therapeutic decisions and treatment Test Procedure If it is unclear from the visual check if the mattress cover interferes with the corner blocks and/or side panels, impacting scale function, please perform the following test: a. Place a known calibrated weight on the center mattress (with mattress cover installed). A 5kg weight is recommended in the instructions for use. b. Execute weighing procedure and record weight. c. Repeat weighing procedure 5-10 times. d. Compare measurements. i. If measurements are within 5 grams of calibrated 5kg weight, mattress assembly is acceptable. ii. If measurements deviate more than +/- 5 grams from the calibrated 5kg weight, it is recommended to use an alternate weighing scale Contact: We regret any inconvenience this may cause.
• Quantity in Commerce: 936 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMT