MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-11-13 for AXIOM MULTIX MT 8395415 NA manufactured by Siemens Medical Solutions Usa, Inc..
[5029257]
A customer reported the 3d tube was stiff to move on the multix mt system and requested service. A siemens engineer was dispatched to the facility. Upon inspection the engineer noticed that het transverse roller was hanging over the edge of the rail. The securing pins for the transverse bridge assembly came out and were not locking the transverse rail to the carriage unstable. Although there have been no report of any injuries in this event, the whole 3d assembly could potentially crash down during an examination. The reported event occurred in the (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[12574136]
The concerned system was repaired by the engineer and returned to service. A customer site visit was planned by the development expert. The reported issue is under investigation and a supplemental report will be submitted once add'l info has been received. Customer's address: (b)(6). This report was filed (b)(6) 2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2014-08382 |
| MDR Report Key | 4269192 |
| Report Source | 01,07 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-10-14 |
| Date Mfgr Received | 2014-10-21 |
| Date Added to Maude | 2014-11-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANASTASIA MASON |
| Manufacturer Street | 51 VALLEY STREAM PKWY. MS D-02 |
| Manufacturer City | MALVERN PA 193551406 |
| Manufacturer Country | US |
| Manufacturer Postal | 193551406 |
| Manufacturer Phone | 6102194834 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | SIEMENSSTRASSE 1 |
| Manufacturer City | FORCHHEIM 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOM MULTIX MT |
| Generic Name | RADIOLOGIC TABLE |
| Product Code | IZZ |
| Date Received | 2014-11-13 |
| Model Number | 8395415 |
| Catalog Number | NA |
| Lot Number | NA |
| 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 MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PKWY. MS D-02 MALVERN PA 19355140 US 19355 1406 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-13 |