FDA Adverse Event
Injury
Summary report: N
BIOGRAPH VISION 450 (6R/EDGE)
MDR report key: 18989528
·
Received March 27, 2024
Report
- Report Number
- 1423253-2024-00002
- Event Type
- Injury
- Date Received
- March 27, 2024
- Date of Event
- March 8, 2024
- Report Date
- August 7, 2024
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- KPS
- UDI-DI
- 04056869238081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON MARCH 8, 2024, OF A CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON (B)(6) 2024. A PERMANENT FINGER INJURY WAS SUSTAINED WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. THERE WERE NO OTHER INJURIES TO ANY OTHER PERSONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1985366 | BIOGRAPH VISION 450 (6R/EDGE) | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION | KPS | SIEMENS MEDICAL SOLUTIONS USA, INC. | 04056869238081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Male | Other |