FDA Adverse Event
Injury
Summary report: N
SOMATOM SENSATION 64
MDR report key: 869520
·
Received June 21, 2007
Report
- Report Number
- 2240869-2007-00008
- Event Type
- Injury
- Date Received
- June 21, 2007
- Date of Event
- May 30, 2007
- Report Date
- May 30, 2007
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- JAK
- PMA / PMN Number
- K040665
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PLASTIC PLEXI-RING BECAME DAMAGED DURING SYSTEM USE.
Description of Event or Problem · 1
WHILE REPOSITIONING A CRITICAL CARE PT, THE RESTRAINING BUCKLE WAS MOVED AND STRUCK THE PLASTIC PLEXI-RING THAT ENCIRCLES THE GANTRY. AS A RESULT, THE PLASTIC PLEXI-RING WAS PUSHED INSIDE THE GANTRY AND BECAME CAUGHT ON THE ROTATING COLLIMATOR. WHILE CAUGHT ON THE ROTATING COLLIMATOR, THE DAMAGED PLASTIC PLEXI-RING BECAME DAMAGED AND LACERATED THE PT'S ELBOW WITH AN EXPOSED, SHARP EDGE. THE LACERATION WAS REPORTEDLY ATTENDED TO BY THE IN-HOUSE ER STAFF AND ALLEGEDLY REQUIRED STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOMATOM SENSATION 64 | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | SIEMENS MEDICAL SOLUTIONS USA, INC. | 8377520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |