MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-29 for AXIOM ICONOS R200 10093961 manufactured by Siemens Healthcare Gmbh, Advanced Therapies.
[143395696]
The system is equipped with safety switches that should stop all system movement in case of collision with foreign object. In the reported case, the applied force to the hand was limited as the cover underneath the table is flexible. When the cover is bent due to the pressure applied by an obstacle, the safety switches should be activated and stop motorized movement immediately. According to the description in the user manual axd3-340. 620. 14 (pages 35 and 53), the operator may release system movements only after ensure that no person is endangered and that the handgrips are properly used. (b)(6). Resubmission of initial report due to report code error.
Patient Sequence No: 1, Text Type: N, H10
[143395697]
It was reported that a patient's hand was trapped under the table top on the axiom iconos r200 system. The hand was caught between the spotfilm device and edge of the table. When the hand got trapped, all table movements were disabled and it was hard to move the table to free patient's hand. As a result of the incident, the patient suffered from a puncture wound and a broken bone. An x-ray examination followed the adverse event. The patient received medical treatment at the facility. Further information regarding the treatment was requested. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2016-30340 |
| MDR Report Key | 8560208 |
| Report Source | FOREIGN |
| Date Received | 2019-04-29 |
| Date of Report | 2016-01-12 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-01-12 |
| Date Added to Maude | 2019-04-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEREDITH ADAMS |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486461 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES |
| Manufacturer Street | SIEMENSSTRASSE 1 |
| Manufacturer City | FORCHHEIM, GERMANY 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOM ICONOS R200 |
| Generic Name | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code | JAA |
| Date Received | 2019-04-29 |
| Model Number | 10093961 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES |
| Manufacturer Address | SIEMENSSTRASSE 1 FORCHHEIM, GERMANY 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-29 |