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 2020-01-09 for DISCOVERY XR656 HD XRA682 manufactured by Ge Hangwei Medical Systems Co., Ltd..
[187254536]
Ge healthcare has initiated a root cause investigation which is ongoing. A follow-up report will be submitted when the investigation has completed. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[187254537]
On (b)(6) 2019, the ge field service engineer (fe) was replacing an ots (overhead tube suspension) counterpoise on a discovery xr656 fixed radiographic device at (b)(6). During replacement of the counterpoise, the fe-> ( s right hand fourth finger was caught between the release tool and the drum frame, resulting in a laceration requiring eight stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613445-2020-00001 |
| MDR Report Key | 9570286 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-11-24 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2020-01-09 |
| 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 | STEVEN WALCZAK |
| Manufacturer Street | 3000 NORTH GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY XR656 HD |
| Generic Name | SYSTEM, X-RAY, STATIONARY |
| Product Code | KPR |
| Date Received | 2020-01-09 |
| Model Number | XRA682 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| Manufacturer Address | WEST AREA OF BUILDING NO.3 NO.1 YONGCHANG NORTH ROAD BEIJING 100176 CH 100176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |