FDA Adverse Event
Injury
Summary report: N
SOMATOM DEFINITION AS
MDR report key: 5719684
·
Received June 13, 2016
Report
- Report Number
- 2240869-2016-42962
- Event Type
- Injury
- Date Received
- June 13, 2016
- Date of Event
- May 13, 2016
- Report Date
- May 17, 2016
- Manufacturer
- SIEMENS HEALTHCARE, CT QT
- Product Code
- JAK
- PMA / PMN Number
- K143400
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CT SYSTEM OPERATOR MANUAL PROVIDES CLEAR WARNINGS TO THE USER TO ALWAYS FIX AND OBSERVE THE PATIENTS POSITIONING DURING SYSTEM MOVEMENTS TO AVOID INJURY. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED TO SIEMENS THAT DURING AN EXAMINATION ON THE SOMATOM DEFINITION AS SYSTEM, A PATIENT SUFFERED AN INJURY TO THE LEFT FINGER. THE PATIENTS FINGER WAS CAUGHT IN THE GAP BETWEEN THE TABLE TOP AND THE TOP SUPPORT DURING TABLE MOVEMENTS. THE SKIN ON THE PATIENTS FINGER WAS TORN AND REQUIRED EIGHT STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376061 | SOMATOM DEFINITION AS | SYSTEM, XRAY, TOMOGRAPHY, COMPUTED | JAK | SIEMENS HEALTHCARE, CT QT | 8098027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |