Device product
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
Z-0792-2016
Product summary
- Firm
- Mizuho OSI
- Event
- Event 72937
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33
- Official record key
device-enforcement:Z-0792-2016
Official wording
Reason: Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.
Code information: Model numbers 7803, 7803AP. Serial numbers 228-261.
Distribution pattern: US, South Africa, Japan and United Arab Emirates.
Derived failure modes
-
Unknown
Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult. If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.