MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for UROSKOP OMNIA MAX 10762473 manufactured by Siemens Healthcare Gmbh.
[145915871]
The monitor support arm is an independent component purchased by siemens from a 3rd party supplier. It is delivered as a part of the whole system. Initial analysis performed at the supplier showed emerging safety element, which is placed between swivel arm and height adjustable carrying arm of the monitor support stand. The safety element serves as a preventive mechanism from dislodging of carrying arm and swivel arm from each other. Emergence of the safety element is first indication that it is undergoing increased wear. In cooperation with the supplier siemens is conducting a thorough investigation to determine the exact root cause. Siemens will be informing all potentially affected users of this issue and issue a corrective action to inspect affected systems replace parts if needed.
Patient Sequence No: 1, Text Type: N, H10
[145915872]
During an on-site visit siemens local service engineer noticed an issue with the uroskop omnia max unit. The gap between carrying arm and swivel arm was not according to specifications. Respective actions to prevent the arms from dislodging have been taken. There is no patient involvement in this event. No injuries are attributed to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004977335-2019-66062 |
| MDR Report Key | 8541100 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-07-31 |
| 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 | 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 | MQB |
| Date Received | 2019-04-23 |
| Model Number | 10762473 |
| 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 | SIEMENSSTR.1 FORCHHEIM, 91301 GM 91301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-23 |