FDA Adverse Event
Malfunction
Summary report: N
TABLE, OPERATING-ROOM, ELECTRICAL
MDR report key: 16689056
·
Received April 6, 2023
Report
- Report Number
- 16689056
- Event Type
- Malfunction
- Date Received
- April 6, 2023
- Date of Event
- March 20, 2023
- Report Date
- March 23, 2023
- Manufacturer
- STILLE AB
- Product Code
- GDC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE VASCULAR STILLIE TABLE WAS ATTEMPTED TO BE UTILIZED FOR THIS CASE AND WAS NOT FUNCTIONING UPON THE START OF THE CASE. THE TABLE TURNED ON AND OFF PRIOR TO STARTING THE CASE WHEN IT WAS BROUGHT INTO THE ROOM BEFORE THE CASE WAS STARTED, BUT AS WE WENT TO MOVE THE TABLE AND SLIDE IT UP AND DOWN IT DID NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1756126 | TABLE, OPERATING-ROOM, ELECTRICAL | GDC | STILLE AB | 402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |