MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-14 for MULTIX TOP ACSS P 475525 manufactured by Siemens Healthcare Gmbh.
[174896126]
Siemens is conducting an investigation of this event. The concerned collimator is built out of inflammable materials according to ul standards and it will self-extinguish in case of thermal effects. This behavior was confirmed during lab testing. A supplemental report will be submitted of additional information becomes available. Internal id # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174896127]
Siemens was informed by its service organization that the user recognized fire and smoke coming out of the collimator on the multix top acss p system. The user put the fire out with an extinguisher. Siemens is unaware of any patient involvement. There are no injuries attribute to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2020-14247 |
| MDR Report Key | 9586759 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-06 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-01-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANASTASIA SOKOLOVA |
| Manufacturer Street | 40 LIBERTY BLVD. MC 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486478 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | SIEMENSTRASSE 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 | MULTIX TOP ACSS P |
| Generic Name | RADIOLOGIC TABLE. |
| Product Code | IZZ |
| Date Received | 2020-01-14 |
| Model Number | 475525 |
| 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 HEALTHCARE GMBH |
| Manufacturer Address | SIEMENSTRASSE 1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-14 |