FDA Adverse Event
Injury
Summary report: N
SYMBIA INTEVO 6
MDR report key: 19083376
·
Received April 10, 2024
Report
- Report Number
- 1423253-2024-00003
- Event Type
- Injury
- Date Received
- April 10, 2024
- Date of Event
- June 14, 2023
- Report Date
- August 7, 2024
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- KPS
- UDI-DI
- 04056869001234
- PMA / PMN Number
- K200474
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON MARCH 11, 2024, OF A CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON (B)(6) 2023. ALLEGEDLY, THE ENGINEER FRACTURED HIS FINGER WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. NO LABELING OR PRODUCT DEFECTS WERE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1893103 | SYMBIA INTEVO 6 | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION | KPS | SIEMENS MEDICAL SOLUTIONS USA, INC. | 10764803 | 04056869001234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |