FDA Adverse Event
Malfunction
Summary report: N
HANA
MDR report key: 12820749
·
Received November 16, 2021
Report
- Report Number
- 2921578-2021-00026
- Event Type
- Malfunction
- Date Received
- November 16, 2021
- Date of Event
- November 10, 2021
- Report Date
- December 21, 2021
- Manufacturer
- MIZUHO OSI
- Product Code
- JEA
- UDI-DI
- 00842430108747
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EVALUATION OF THE DEVICE FOUND BROKEN PARTS INSIDE, LIKELY FATIGUE FRACTURES DUE TO REPEATED OVER-TORQUING OF THE BRAKE BY THE USERS.
Description of Event or Problem · 0
IN THE MIDDLE OF SURGERY THE LEG JOINT LOCK BROKE AND IT FELL TO THE FLOOR.
Description of Event or Problem · 0
IN THE MIDDLE OF SURGERY THE LEG JOINT LOCK BROKE AND IT FELL TO THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1721189 | HANA | OPERATING TABLE | JEA | MIZUHO OSI | 6875 | 00842430108747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |