Device product
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Z-0203-2024
Product summary
- Firm
- Coapt LLC
- Event
- Event 93137
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 247 devices
- Official record key
device-enforcement:Z-0203-2024
Official wording
Reason: Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Code information: UDI/DI +B618E0/$+201907E00256B, all Gen2 system serial number
Distribution pattern: Worldwide distribution - US Nationwide and the country of Sweden.
Derived failure modes
-
Unknown
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.