FDA MedWatch - CARESCAPE R860 Ventilator by GE Healthcare

Class I Recall - Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: CARESCAPE R860 Ventilator by GE Healthcare: Class I Recall - Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down AUDIENCE: Patient, Health Professional, Risk Manager, Pulmonology, Pediatrics ISSUE: GE Healthcare is recalling CARESCAPE R860 ventilator backup batteries, including replacement backup batteries, manufactured on or after April 1, 2019, because the batteries may run out before they are expected to do so. If the ventilator is running on battery power only when the battery fails, ventilation could stop completely, preventing the patient from receiving oxygen and breathing support.  Lack of oxygen (hypoxia), especially if it occurs over a long period, can cause serious injury and death.   There have been 1,553 complaints, one injury, and no deaths associated with the use of this device.   For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The CARESCAPE R860 ventilator is intended to provide mechanical ventilation or breathing support to infants (neonatal), children (pediatric), and adult patients weighing 0.25 kg and above. RECOMMENDATIONS: On April 18, 2022, GE Healthcare issued an Urgent Medical Device Correction letter to customers. The letter recommended that customers and/or users:  Perform a Battery Performance Test. Continue to use the affected ventilators while the ventilator is connected to an AC main power source that is supported by backup emergency power. If use of the ventilator by battery power is necessary, for example during transport where alternative options are limited, follow standard clinical practice when it comes to administering the appropriate readily accessible alternative ventilation, such as a bag-valve system.   Replace the batteries when necessary, before patient use. Keep the ventilator connected to the AC main power source when it is not in use, even when it is in storage. This will prevent battery discharge and degradation.  Replace backup batteries at a minimum of every three years.  Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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