FDA Adverse Event
Injury
Summary report: N
SKYTRON LLC OR TABLES
MDR report key: 22028920
·
Received May 15, 2025
Report
- Report Number
- MW5170430
- Event Type
- Injury
- Date Received
- May 15, 2025
- Date of Event
- May 5, 2025
- Report Date
- May 12, 2025
- Manufacturer
- SKYTRON, LLC.
- Product Code
- GDC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
OPERATING ROOM 5 REPORTED FIRE FROM THE SKYTON OPERATION TABLE MODEL 3602 SAW A SPARK FROM THE BED, AND SHE THINKS HER BED WAS ON FIRE. BIOMED WAS ON SITE TO ANALYZE THE ISSUE AND IT WAS FOUND THAT THE TABLE WAS WET AROUND THE POWER CODE AREA. THERE WAS NO HARM TO THE PATIENT AND STAFF ON THIS REPORTED ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88707 | SKYTRON LLC OR TABLES | TABLE, OPERATING-ROOM, ELECTRICAL | GDC | SKYTRON, LLC. | 3602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |