FDA Adverse Event
Injury
Summary report: N
AXIOM LUMINOS DRF
MDR report key: 4102568
·
Received September 16, 2014
Report
- Report Number
- 2240869-2014-06868
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- August 13, 2014
- Report Date
- August 20, 2014
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- OWB
- PMA / PMN Number
- K062623
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PATIENT EXAMINATION ON THE AXIOM LUMINOS DRF SYSTEM A LONG-LEG TECHNIQUE WAS USED. THE PATIENT TABLE WAS MOVED 70 CM AND 90 DEGREES UPWARDS WHEN THE PATIENT FELT NAUSEOUS AND FELL OFF THE TABLE. THE TWO RADIOGRAPHERS PRESENT IN THE EXAM ROOM UNSUCCESSFULLY ATTEMPTED TO CATCH THE PATIENT. THE PATIENT AND BOTH RADIOGRAPHERS RECEIVED SOME BRUISES AS A RESULT OF THE INCIDENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572058 | AXIOM LUMINOS DRF | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY | OWB | SIEMENS MEDICAL SOLUTIONS USA, INC. | 10094200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |