MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-26 for O2 BI70002000 manufactured by Sanmina -sci Systems.
[186731952]
The system was serviced in the field. There was a loss of calibration files and a loss of communication between the mvs and ias computers. The field service engineer (fse) checked, cleaned and re-seated all ethernet cables and connections. The fse reloaded the mvs configuration files. He tested ethernet communication, verify complete boot, system operation and re-connectivity with umbilical dis-connection and re-connection. He completed power cycles and performed a system test. The system performed to specification. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186731953]
Medtronic received information regarding an imaging system used outside of procedure. It was reported that the image acquisition station (ias) was not connecting to the mobile viewing station (mvs) and had an error "unable to connect to gain calibration file path". The radiologic technologist (rt) tried multiple reboots and the issue did not resolve. There was no patient present at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006544299-2020-00103 |
| MDR Report Key | 9883691 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-24 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2018-10-08 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | SANMINA -SCI SYSTEMS |
| Manufacturer Street | KM 15.5 NO. 29, PLANT 06 |
| Manufacturer City | CARR. CHAPALA-GUADALAJARA,JAL 45640 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 45640 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O2 |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-26 |
| Model Number | BI70002000 |
| Catalog Number | BI70002000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANMINA -SCI SYSTEMS |
| Manufacturer Address | KM 15.5 NO. 29, PLANT 06 CARR. CHAPALA-GUADALAJARA,JAL 45640 MX 45640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |