FDA Adverse Event
Injury
Summary report: N
AXIOM MULTIX MT
MDR report key: 2885433
·
Received December 26, 2012
Report
- Report Number
- 2240869-2012-11354
- Event Type
- Injury
- Date Received
- December 26, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 6, 2012
- Manufacturer
- SIEMENS AG
- Product Code
- IZZ
- PMA / PMN Number
- K971452
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY INVESTIGATION SHOWED THAT THE TABLE BRAKES WERE ACTIVATED WHEN THE INCIDENT OCCURRED. THE BREAKING FORCE OF THE TABLE WAS TOO LOW POTENTIALLY CAUSING THE TABLE TO MOVE. THE INCIDENT IS UNDER INVESTIGATION. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT A FEMALE PATIENT WAS HOLDING TO THE EDGE OF THE TABLE WHILE SITTING ON THE TABLETOP ON THE AXIOM MULTIX MT SYSTEM. THE TABLE MOVED AND THE PATIENT'S FINGER GOT CAUGHT BETWEEN THE BUCKY AND THE TABLE TOP. THE PATIENT SUFFERED A FRACTURE TO HER 5TH (PINKY) FINGER ON THE LEFT HAND. THE PATIENT SOUGHT MEDICAL ATTENTION AT THE ORTHOPEDIC DEPARTMENT OF THE FACILITY. THE REPORTED EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIOM MULTIX MT | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED | IZZ | SIEMENS AG | 08395399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |