FDA Adverse Event
Malfunction
Summary report: N
RADPRO MOBILE X-RAY SYSTEM
MDR report key: 11027069
·
Received December 17, 2020
Report
- Report Number
- 11027069
- Event Type
- Malfunction
- Date Received
- December 17, 2020
- Date of Event
- October 12, 2020
- Report Date
- October 28, 2020
- Manufacturer
- CANON MEDICAL SYSTEM, USA, INC.
- Product Code
- IZL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 0
TWO HORIZONTAL LINES ON THE DETECTOR REPRESENTING AN ARTIFACT WERE SEEN, SO THE PORTABLE X-RAY UNIT WAS TAKEN OUT OF SERVICE UNTIL THE DETECTOR COULD BE EVALUATED AND REPLACED. NO DELAY IN TREATMENT OR DIAGNOSIS.
Description of Event or Problem · 1
TWO HORIZONTAL LINES ON THE DETECTOR REPRESENTING AN ARTIFACT WERE SEEN, SO THE PORTABLE X-RAY UNIT WAS TAKEN OUT OF SERVICE UNTIL THE DETECTOR COULD BE EVALUATED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1498618 | RADPRO MOBILE X-RAY SYSTEM | SYSTEM, X-RAY, MOBILE | IZL | CANON MEDICAL SYSTEM, USA, INC. | SM-40 HF-B-D-C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |