MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,company representative, report with the FDA on 2015-06-26 for DISCOVERY XR656 manufactured by Ge Hangwei Medical Systems Co., Ltd..
[6047009]
It was reported that during installation of the discovery xr656 wall stand, it was identified that the counterweights within the wall stand column were not moving up and down as the detector arm was moved. At that time, the vendor field engineer (fe) removed the wall stand top cover to check the counterweights and identified the belt that is responsible for lifting the counterweights was loose. As the fe was troubleshooting this event, the fe put their hand under the suspended counterweights when the counterweights suddenly fell and impacted the field engineer's finger. The field engineer received a fracture and laceration on their left ring finger. The treatment that was completed was to clean and suture the wound.
Patient Sequence No: 1, Text Type: D, B5
[13955947]
The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. 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: N, H10
[65681845]
Ge healthcare's investigation has concluded and the cause of this event was determined to be an installation error as the installer should never position their hands directly under the counterweights during servicing or installation of this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613445-2015-00005 |
| MDR Report Key | 4871752 |
| Report Source | 01,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-06-26 |
| Date of Report | 2015-05-29 |
| Date of Event | 2015-05-29 |
| Date Mfgr Received | 2015-07-19 |
| Device Manufacturer Date | 2014-07-20 |
| Date Added to Maude | 2015-06-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 540 W. NORTHWEST HIGHWAY |
| Manufacturer City | BARRINGTON IL 600103076 |
| Manufacturer Country | US |
| Manufacturer Postal | 600103076 |
| Manufacturer Phone | 8472774719 |
| Manufacturer G1 | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| Manufacturer Street | NO. 2 YONG CHANG NORTH RD. |
| Manufacturer City | BEIJING, 100176 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 100176 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY XR656 |
| Generic Name | SYSTEM, X-RAY, TOMOGRAPHIC |
| Product Code | IZF |
| Date Received | 2015-06-26 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| Manufacturer Address | NO. 2 YONG CHANG NORTH RD. BEIJING, 100176 CH 100176 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-26 |