Device product
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Z-2035-2019
Product summary
- Event
- Event 83220
- Status
- Terminated
- Classification
- Class II
- Quantity
- 295 customer sites have the affected software versions
- Official record key
device-enforcement:Z-2035-2019
Official wording
Reason: Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Code information: All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.
Distribution pattern: Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.
Derived failure modes
-
Unknown
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.