FDA Adverse Event
Malfunction
Summary report: N
TRIOS ORTHOPEDIC TRAUMA TOP
MDR report key: 9607495
·
Received January 20, 2020
Report
- Report Number
- 2921578-2020-00006
- Event Type
- Malfunction
- Date Received
- January 20, 2020
- Date of Event
- January 13, 2020
- Report Date
- March 6, 2020
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 0
ROOT CAUSE DETERMINED TO BE USER ERROR; THE TABLE HAS BEEN INSPECTED BY BOTH THE MIZUHO OSI CERTIFIED HOSPITAL CLINICAL ENGINEER AND THE MIZUHO OSI FIELD SERVICE ENGINEER. IT IS DEEMED FREE FROM DEFECT AND SAFE TO USE, THERE IS NO REASON WHY THE TABLE ORTHO TOP COULD FALL BEYOND IT NOT BEING ATTACHED AND LOCKED PROPERLY BY THE USER. THE TABLE WAS NOT DAMAGED AS A RESULT OF THIS USER ERROR AND THE PATIENT WAS NOT INJURED. THE TABLE CAN CONTINUE TO BE USED.
Description of Event or Problem · 0
IT WAS REPORTED THE FOOT END OF THE TABLE DROPPED DOWN TO THE GROUND, WHILE THE PATIENT WAS ON IT.
Description of Event or Problem · 1
IT WAS REPORTED THE FOOT END OF THE TABLE DROPPED DOWN TO THE GROUND, WHILE THE PATIENT WAS ON IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68778 | TRIOS ORTHOPEDIC TRAUMA TOP | SURGICAL OPERATING TABLE | JEA | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 7855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |