MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-04 for ARTIS ZEEGO 10280959 manufactured by Siemens Healthcare Gmbh.
[104570240]
(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. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[104570241]
It was reported to siemens that a malfunction occurred while operating the artis zeego system. While moving from the parking position, the zeego lowered approximating 15 centimeters before the emergency brake engaged. After a system reboot the system continued to operate normally. There is no report of impact to the state of health of any patient or user involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2018-21484 |
| MDR Report Key | 7396003 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-04 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-03-13 |
| Date Facility Aware | 2018-03-13 |
| Report Date | 2018-03-13 |
| Date Reported to Mfgr | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-04-04 |
| 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 ZEEGO |
| Generic Name | SYSTEM, X-RAY, ANGIOGRAPHIC |
| Product Code | IZI |
| Date Received | 2018-04-04 |
| Model Number | 10280959 |
| 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 | 2018-04-04 |