MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-07-28 for DPX BRAVO manufactured by Ge Medical Systems (china) Co. Ltd..
[2129545]
It was reported that while servicing this system, a ge healthcare field engineer sustained a cut on his right finger that required three stitches. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710602-2011-00002 |
| MDR Report Key | 2187857 |
| Report Source | 01,06 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-28 |
| Date of Event | 2011-06-28 |
| Date Mfgr Received | 2011-06-29 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2011-08-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE MEDICAL SYSTEMS (CHINA) CO. LTD. |
| Manufacturer City | WUXI, JIANGSU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DPX BRAVO |
| Generic Name | BONE DENSITOMETER |
| Product Code | KGI |
| Date Received | 2011-07-28 |
| ID Number | DEVICE ID BT-20923 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS (CHINA) CO. LTD. |
| Manufacturer Address | WUXI, JIANGSU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-28 |