MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-10-31 for AXIOM ARISTOS FX 07414803 manufactured by Siemens Ag.
[977761]
The detector was in the table mode. The detector did not maintain the horizontal position, and angled down toward the floor. The detector hit the technologist on the right foot in the middle of the foot, causing soreness of the foot. The technologist returned to work the following day. There was a pt in the room, but the pt was not involved in this event. A siemens service rep checked the unit, and found 3 of the 4 bolts that hold the detector horizontal had the heads broken off. The detector was replaced, and the original detector, along with the broken bolts, was returned to the factory for eval.
Patient Sequence No: 1, Text Type: D, B5
[8243927]
There was no serious injury relating to this event. The risk of a death or serious injury is extremely low, however, we reported this malfunction in the abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2008-00023 |
| MDR Report Key | 1218860 |
| Report Source | 05,06 |
| Date Received | 2008-10-31 |
| Date of Report | 2008-10-13 |
| Date of Event | 2008-10-13 |
| Date Mfgr Received | 2008-10-13 |
| Date Added to Maude | 2009-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL RYN |
| Manufacturer Street | 51 VALLEY STREAM PKWY. MS E-50 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104484634 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | SIEMENSTRASSE 1 |
| Manufacturer City | FORCHHEIM |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOM ARISTOS FX |
| Generic Name | SYSTEM, X-RAY, STATIONARY |
| Product Code | IZO |
| Date Received | 2008-10-31 |
| Model Number | 07414803 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS AG |
| Manufacturer Address | SIEMENSTRASSE 1 FORCHHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-31 |