MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-19 for ARTIS ZEE BIPLANE 10094141 manufactured by Siemens Healthcare Gmbh.
[102740859]
(b)(4). 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
[102740860]
It was reported to siemens that a malfunction occurred while operating the artis zee biplane system. During an interventional procedure, the user reported receiving an error message "tube hot, have a break. ". The patient was safely removed from the system and transferred to an alternate system where the procedure was completed. We are unaware of any impact to the state of health of the patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2018-17733 |
| MDR Report Key | 7348183 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-19 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-15 |
| Date Facility Aware | 2018-02-23 |
| Report Date | 2018-02-23 |
| Date Reported to Mfgr | 2018-02-23 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-19 |
| 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 | 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 |
| Manufacturer Street | SIEMENSTRASSE 1 |
| Manufacturer City | FORCHEIM, 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 | ARTIS ZEE BIPLANE |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2018-03-19 |
| Model Number | 10094141 |
| 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 FORCHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-19 |