TRIOS, TABLE BASE
Report
- Report Number
- 2921578-2024-00013
- Event Type
- Malfunction
- Date Received
- August 14, 2024
- Date of Event
- July 25, 2024
- Report Date
- October 31, 2024
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEA
- UDI-DI
- 00842430103957
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- 501
Narratives
PER THE INFORMATION OBTAINED FROM INVESTIGATION AND DEVICE EVALUATION, AN INTERMITTENT PAUSING OF THE TABLE COLUMN AFTER 36" ALONG WITH LOW VOLTAGE OF THE BATTERIES WAS OBSERVED. AFTER PERFORMING THE COLUMN CALIBRATION AND BATTERY RE-CHARGE, THE REPORTED ISSUE OF "SPUTTERING" OR "SHAKING" WAS NOT OBSERVED/REPRODUCED. POTENTIOMETER, BATTERIES AND POWER CORD WERE REPLACED BY THE MANUFACTURER FOLLOWING THE INCIDENT.
WHILE PATIENT WAS ON THE TABLE, THE TRIOS TABLE SYSTEM BEGAN SHAKING OR "SPUTTERING" UNCONTROLLABLY. THE SPUTTERING WAS EXCESSIVE ENOUGH DURING THIS LATEST EPISODE THAT THE TEAM IN THE ROOM THOUGHT THE PATIENT MAY FALL OFF THE TABLE. SPUTTERING OCCURED INTERMITTENTLY UNTIL IT GOT TO 39 INCHES AND UP WHEN IT BECAME ITS WORST.
WHILE PATIENT WAS ON THE TABLE, THE TRIOS TABLE SYSTEM BEGAN SHAKING OR "SPUTTERING" UNCONTROLLABLY. THE SPUTTERING WAS EXCESSIVE ENOUGH DURING THIS LATEST EPISODE THAT THE TEAM IN THE ROOM THOUGHT THE PATIENT MAY FALL OFF THE TABLE. SPUTTERING OCCURED INTERMITTENTLY UNTIL IT GOT TO 39 INCHES AND UP WHEN IT BECAME ITS WORST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535097 | TRIOS, TABLE BASE | OPERATING TABLE | JEA | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 7803 | 00842430103957 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |