Early Alert: Infant Resuscitation System Issue from GE HealthCare
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use.
Affected devices:
| Product Name | Ref Number | GTIN |
|---|---|---|
| Giraffe6 Stand-Alone Infant Resuscitation System | 2082663-001 2082663-002 M1241424 | 00840682100151 00840682100175 |
| Giraffe6 Warmer with Integrated Resuscitation System (iRes) | M1118179 | 00840682103923 |
| Panda Warmer with Integrated Resuscitation System (iRes) | M1112198 | V2.0 (Hybrid) 00840682152716 V1.0 (US) 00840682152709 |
| Panda Freestanding Warmer | 2063568-001 | 00840682103916 |
| Service Blender Includes Standoffs and Knob | M1091607-R | N/A |
Full List of Affected Blender Serial Numbers
What to Do
Identify and remove affected devices from use until they can be corrected. If affected devices must be used prior to correction, follow the additional precautions below.
On May 8, GE HealthCare sent all affected customers a letter recommending the following actions:
- Inspect all Giraffe and Panda Warmers with Integrated Resuscitation System (iRes) and Giraffe Stand-alone Infant Resuscitation System devices to determine if the device has an affected blender.
- If the device has an affected blender, remove the unit from patient use and contact a GE HealthCare Service Representative at the number listed below.
- If a device with an affected blender must be used prior to being corrected by GE HealthCare, follow the instructions below:
- Follow the instructions in the device User Manuals, including all pre-use checkout instructions. These manuals also include the following requirements and warnings:
- Pre-use checkout: Before each operation, inspect the resuscitation system for damage, such as broken knobs and fittings or gauges with indicator needles that are not at 0.
- Do not do the pre-use checkout procedure, service, or calibrate the device with the patient in the device. Make sure all pre-use checkout procedure steps are correctly completed before each patient use. If a step fails, do not use the device.
- Perform the blender Multipoint Oxygen Concentration Check as described in Section 2.5.1 of the Service Manual M1128929.
- If the pre-use checkout passes and the Multipoint Oxygen Concentration Check meets specifications, GE HealthCare recommends oxygen concentration should be verified with an independent oxygen analyzer on a frequent basis until the unit is corrected.
- If the pre-use check does not pass (e.g., the blender knob is loose) or the Multipoint Oxygen Concentration Check does not meet specifications, remove the unit from patient use.
- Note: User and service manuals are available on the Customer Documentation Portal: https://www.gehealthcare.com/support/manuals
- Follow the instructions in the device User Manuals, including all pre-use checkout instructions. These manuals also include the following requirements and warnings:
- Evaluate existing service stock for affected blenders. The blender model number and serial number are visible on the packaging. The serial number is visible on the blender. Quarantine any affected blenders.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
GE HealthCare stated that the air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, which can affect the delivered oxygen concentration. If this occurs, the system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
As of May 20, GE HealthCare has not reported any serious injuries or deaths associated with this issue.
Device Use
The Integrated Resuscitation and Standalone Infant Resuscitation Systems provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures during manual ventilation to the infant.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact GE HealthCare Service at 1-800-437-1171.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.