MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-10-26 for PRESTIGE SI manufactured by Ge Medical Systems, Llc.
[2339199]
It was reported that a pt sustained a triple fracture (leg and ankle) after the bench where she was sitting dropped. The table was is in vertical position, and the pt was sitting on the bench at approximately 70 cm height. Ge healthcare's investigation is ongoing. A f/u report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2011-00138 |
| MDR Report Key | 2314778 |
| Report Source | 01,06 |
| Date Received | 2011-10-26 |
| Date of Report | 2011-10-26 |
| Date of Event | 2011-09-30 |
| Date Mfgr Received | 2011-09-30 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2011-11-01 |
| 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 | 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, LLC |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTIGE SI |
| Generic Name | FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | LZI |
| Date Received | 2011-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-26 |