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 2019-03-27 for MOBILETT XP HYBRID 01818454 manufactured by Siemens Healthcare Gmbh.
[140123203]
(b)(4). The power cable on the concerned unit was replaced and the system was returned to use. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[140123204]
Siemens was informed about an incident on the mobilett xp hybrid. When the operator plugged the unit system into the wall outlet, a blue spark was seen. There is no patient involvement in this case as the spark occurred when the system batteries were plugged to be charged. The incident occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2019-73957 |
| MDR Report Key | 8457839 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-03-13 |
| Date Facility Aware | 2019-03-13 |
| Report Date | 2019-03-13 |
| Date Reported to Mfgr | 2019-03-13 |
| Date Mfgr Received | 2019-05-21 |
| Date Added to Maude | 2019-03-27 |
| 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 | 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 | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN, 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILETT XP HYBRID |
| Generic Name | MOBILE X-RAY SYSTEM |
| Product Code | IZL |
| Date Received | 2019-03-27 |
| Model Number | 01818454 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE GMBH |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN, 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-27 |