MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for UROSKOP OMNIA MAX 10762473 manufactured by Siemens Healthcare Gmbh.
[142800518]
Resubmission of initial report as per fda on (b)(6) 2019. Additional information was requested by factory experts. Investigation is on-going. A supplemental report will submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[142800519]
Siemens was informed by its service organization about an incident when the monitor suspension on the uroskop omnia max detached from the support arm. The monitor suspension was caught by the monitor cable, thus, preventing the fall. There are no injuries attributed to this event. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2018-59618 |
| MDR Report Key | 8531623 |
| Date Received | 2019-04-19 |
| Date of Report | 2018-12-02 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2018-12-02 |
| Date Added to Maude | 2019-04-19 |
| 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 | 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 | SIEMENSSTR.1 |
| Manufacturer City | FORCHHEIM, 91301 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UROSKOP OMNIA MAX |
| Generic Name | STATIONARY X-RAY SYSTEM |
| Product Code | JAA |
| Date Received | 2019-04-19 |
| Model Number | 10762473 |
| 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 | SIEMENSSTR.1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-19 |