Device product
Panda¿ Freestanding 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-1549-2014
Product summary
- Firm
- GE Healthcare
- Event
- Event 68067
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-1549-2014
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: HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979
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