MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for GE 1.5T SIGNA HDX MR SYSTEM manufactured by Ge Medical Systems, Llc.
[188631573]
Unique identifier: udi not required. There are no additional device identification numbers. 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
[188631574]
It was reported to ge healthcare that a patient undergoing a breast mri exam sustained a non-displaced rib fracture. The patient was positioned normally upon the breast coil as instructed by the mri technologist and there were no reports of compression on the sides or top of the magnet during movement into the system. The patient made no complaint at the time of exam, and only reported the injury after having been evaluated by her physician which included imaging, confirming the rib fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183553-2020-00005 |
| MDR Report Key | 9825385 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2005-05-09 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JACQUI BUDDE |
| Manufacturer Street | 3200 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE 1.5T SIGNA HDX MR SYSTEM |
| Generic Name | NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-03-12 |
| 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 | 3200 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |