Device product
Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Z-1550-2014
Product summary
- Firm
- GE Healthcare
- Event
- Event 68067
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-1550-2014
Official wording
Reason: Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
Code information: HDJS52856 HDJS52857 HDJS52858 HDJS52859 HDJS52860 HDJS52861 HDJS52862 HDJS52863 HDJS52864 HDJS52865 HDJS52800 HDJS52801 HDJS52802 HDJS52803 HDJS52804
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Device software or design
software may be defective and may cause user-set alarm limits to result in