—#193313

Product

Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators.

FDA product code: CBK — Ventilator, Continuous, Facility Use
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K111116, K142679
Affected lot / code info: Field Replacement Unit kits PN: 1009-5682-000-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V) and PN: 5856787-S (BTRY SEALED LEAD ACID RECHARGEABLE 12V PAIR).

Why it was recalled

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter the consignees via mail on 04/18/2022. The letter describes the product, problem and actions to be taken. The customers instructed to take the following actions: 1. You can continue to use the affected ventilators while the ventilator is connected to an AC mains power source that is supported by backup emergency power. 2. If it is absolutely necessary to use the ventilator by relying on the battery (such as during required transport where there are no other options), ensure you follow standard clinical practice of having a readily accessible means of appropriate alternative ventilation (for example a bag-valve system) and personnel with the capability to administer this alternative means at all times. 3. Immediately after receiving this communication, perform the Battery Performance Test as described in Appendix A. Replace the batteries when necessary, before patient use. 4. When not in patient use, it is recommended that the device always remains connected to the AC mains power source to prevent battery discharge and degradation, even when in storage. 5. It is recommended that the Battery Performance Test be completed every three months as described in Appendix A. 6. If the device has been in storage for over three months, perform the Battery Performance Test as described in Appendix A prior to use. 7. The backup batteries must be replaced at a minimum every three years. 8. Complete the attached Medical Device Notification Acknowledgement Response form and send to FMI34126RC.BATTERY@ge.co If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) to AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and OUS (internationally) to Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Columbia, Cote D'Ivoire, Mexico, Uruguay, United Kingdom, United Arab Emirates, Turkey, Thailand, Tanzania, Sweden, Spain, Singapore, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Panama, Omar, Norway, Nigeria, Nicaragua, New Zealand, Netherlands, Malaysia, Latvia, Kuwait, Korea, Kenya, Kazakhstan, Japan, Italy, Ireland, Indonesia, India, Hungary, Germany, France, Finland, Estonia, Egypt, Ecuador, Denmark, Czech Republic.

Timeline

Recall initiated: 2022-04-18
Posted by FDA: 2022-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.