MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-14 for OPTIMA XR240AMX 5555000 manufactured by Ge Medical Systems, Llc.
[138827875]
A ge healthcare investigation has been initiated and is ongoing. A follow-up mdr will be provided when ge healthcare's investigation has been completed. Weight: although requested, the user was unable to provide the patient weight. Unique identifier: (b)(4). Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[138827876]
On (b)(6) 2019, the radiographic technologist at (b)(6) in the united states reported that when they were performing a chest x-ray using their optima xr240amx mobile radiographic system, the technologist mistakenly took the image with the detector upside down. After the image appeared on the system, it came up on the acquisition screen upside down and displayed the correct external lead marker. The technologist then corrected the image orientation by rotating the image 180 degrees but failed to change the dicom orientation tags after rotating the image. Therefore, when the image was sent to pacs, the image was hanging correctly and showed the correct external annotation marker, but the dicom orientation tag was incorrect. Therefore, the image read l (left) with an external marker and r (right) for the dicom tag. The emergency room (er) physician read the images using the dicom orientation tag and had a chest tube placed into the incorrect lung that resulted in a pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2019-00002 |
| MDR Report Key | 8421720 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-14 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-03-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIMA XR240AMX |
| Generic Name | SYSTEM, X-RAY, MOBILE |
| Product Code | IZL |
| Date Received | 2019-03-14 |
| Model Number | 5555000 |
| Lot Number | DF2401800289WK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 NORTH GRANDVIEW BOULEVARD WAUKESHA, WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-14 |