FDA Adverse Event
Injury
Summary report: N
MAGNETOM SYKRA
MDR report key: 4102573
·
Received September 15, 2014
Report
- Report Number
- 2240869-2014-07261
- Event Type
- Injury
- Date Received
- September 15, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 5, 2014
- Manufacturer
- SIEMENS HEALTHCARE
- Product Code
- LNH
- PMA / PMN Number
- K111242
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SIEMENS HAS EVALUATED THE SYSTEM AND NO FAILURE WAS DETECTED. THE SYSTEM IS OPERATING WITHIN SPECIFICATIONS. THE OPERATORS MANUAL PROVIDES WARNINGS TO THE USER REGARDING THE INTRODUCTION OF FERROUS METALS IN THE EXAM ROOM. THIS REPORT IS BEING FILED WITH THE FDA (B)(4) 2014.
Description of Event or Problem · 1
IT WAS REPORTED TO SIEMENS THAT A PATIENT WAS POSITIONED ON THE PATIENT TABLE IN THE HOME POSITION PRIOR TO EXAM. A FERROUS METAL STOOL WAS PLACED CLOSE TO THE SYSTEM BY THE OPERATOR. THE STOOL WAS IMMEDIATELY ATTRACTED TO THE MAGNET, STRIKING THE PATIENT IN THE FACE RESULTING IN A FRACTURED NOSE. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PATIENTS CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569016 | MAGNETOM SYKRA | SYSTEM, NUCLEAR MAG. RESONANCE IMG | LNH | SIEMENS HEALTHCARE | 10432915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |