Device product
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.
Z-0848-2014
Product summary
- Event
- Event 67100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 237 units
- Official record key
device-enforcement:Z-0848-2014
Official wording
Reason: Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
Code information: Part number 6481779
Distribution pattern: Worldwide Distribution US, Canada and Japan.
Derived failure modes
-
Unknown
Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.