FDA Adverse Event
Other
Summary report: N
X-RAY C-ARM
MDR report key: 21677717
·
Received March 24, 2025
Report
- Report Number
- MW5168031
- Event Type
- Other
- Date Received
- March 24, 2025
- Date of Event
- January 13, 2025
- Report Date
- March 17, 2025
- Manufacturer
- PHILIPS/PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- OXO
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DURING A PROCEDURE, THE COVERING OF THE PART OF THE X-RAY C-ARM THAT ATTACHES TO THE CEILING FELL DOWN AND DANGLED FROM THE SAFETY CHAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2099991 | X-RAY C-ARM | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE | OXO | PHILIPS/PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |