MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-11-07 for DEFINLUM 8000 5131070 NA manufactured by Ge Hangwei Medical Systems Co., Ltd..
[3285004]
It was previously reported that the proteus xr/a table drove past the lower limit safety switches. The definlum 8000 table circuit board has similar technology, therefore, creating a similar injury prospectus. No injury was reported. The concern is for a toe pinch hazard, if the operator's foot would become trapped between the outer covers and the floor or operating pedals.
Patient Sequence No: 1, Text Type: D, B5
[10439648]
There was no event reported for the definlum 8000 x-ray system, therefore, no patient was involved. Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613445-2007-00021 |
| MDR Report Key | 2954117 |
| Report Source | 07 |
| Date Received | 2007-11-07 |
| Date of Report | 2007-10-17 |
| Date of Event | 2007-10-17 |
| Date Added to Maude | 2013-02-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
| Manufacturer Street | NO.1, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.ZONE |
| Manufacturer City | BEIJING PR |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFINLUM 8000 |
| Product Code | IZF |
| Date Received | 2007-11-07 |
| Model Number | 5131070 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | NO.1, YONG CHANG NORTH RD. BEIJING ECON.&TECH.DEV.ZONE BEIJING PR CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-07 |