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 2019-04-23 for MOBILETT XP HYBRID 01818454 manufactured by Siemens Healthcare Gmbh.
[142794734]
Resubmission of initial report as per fda on 4/3/2019. The system was checked by siemens local service. The engineer noticed that one screw was loose. The engineer re-attached the screw and tightened the peripheral screws. The system was brought back to specifications. Customers address: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[142794735]
It was reported that during a surgery while using the mobilett xp hybrid system, a washer fell down. The washer hit the patient; however, it did not comprise the operation area. There are no injuries related to this incident. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2017-02060 |
| MDR Report Key | 8540824 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-23 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-03-30 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | 2019-04-23 |
| 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 | 2019-04-23 |