MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-23 for ARTIS ZEE FLOOR 10094135 manufactured by Siemens Healthcare Gmbh- At.
[184449900]
Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[184449901]
It was reported to siemens that an adverse event occurred while operating the artis zee floor system. During an interventional procedure, the user reported that the system went into bypass mode. Additional information was provided that the patient passed away. Siemens has requested additional information in order to conduct an investigation of the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2020-23780 |
| MDR Report Key | 9865135 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 4486461 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH- AT |
| Manufacturer Street | SIEMENSSTRASSE 1 |
| Manufacturer City | FORCHHEIM, GERMANY 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIS ZEE FLOOR |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-23 |
| Model Number | 10094135 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH- AT |
| Manufacturer Address | SIEMENSSTRASSE 1 FORCHHEIM, GERMANY 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-23 |