MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-11 for OPTIMA NX 9SYS0088-D NA manufactured by Ge Medical Systems, Llc.
[405522]
It was reported that when setting up a optima nx system for a tomographic scan, the operator rotated the gantry to the tomo start position resulting in the detector head colliding with the pt arm. The pt suffered a broken arm. A static scan of the pt using the same system had just been completed prior to this incident. The operator acknowledged a user interface prompt to automatically move the camera from the static scan to the tomo start position. The pt was not appropriately positioned for the commanded motion. The pt's arm was caught between a stretcher and one of the camera's detector heads when the camera repositioned. Although the system uses a clutch mechanism to minimize the force applied by the detector in the event of collision, this injury still occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2005-00032 |
| MDR Report Key | 646011 |
| Report Source | 05 |
| Date Received | 2005-11-11 |
| Date of Report | 2005-11-11 |
| Date of Event | 2005-10-05 |
| Date Mfgr Received | 2005-10-14 |
| Device Manufacturer Date | 1995-06-01 |
| Date Added to Maude | 2005-11-17 |
| 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 | 0 |
| Manufacturer Contact | MARY OVERLAND, PH.D. |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD, W-400 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482402 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Street | 3000 N, GRANVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53188 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIMA NX |
| Generic Name | NUCLEAR MEDICINE |
| Product Code | IYY |
| Date Received | 2005-11-11 |
| Model Number | 9SYS0088-D |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 635519 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US |
| Baseline Brand Name | OPTIMA NX |
| Baseline Generic Name | NUCLEAR MEDICINE |
| Baseline Model No | 9SYS0088-D |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-11 |