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 2020-03-31 for GE 1.5T SIGNA HDX MR SYSTEM manufactured by Ge Medical Systems, Llc.
[188328614]
There are no additional device identification numbers. The investigation by ge healthcare (gehc) has been completed. The mr scanner appeared to be functioning according to specification and the breast coil was fully functional. The ge 1. 5t hd breast array is designed to accommodate best female anatomy and padding is provided to relieve any pressure points, which would distribute the patient's weight over entire anterior surface of the chest. Based on the information provided, there is no apparent root cause of the injury. The scanner and breast coil were working as expected and the technologist demonstrated good clinical care of the patient from preparation of the scan to attentiveness during the exam. No further actions are planned by gehc.
Patient Sequence No: 1, Text Type: N, H10
[188328615]
Ge healthcare recently became aware that a patient who underwent an mri breast exam in 2016 sustained a displaced rib fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183553-2020-00006 |
| MDR Report Key | 9906864 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-02 |
| Date of Event | 2016-04-10 |
| Date Mfgr Received | 2020-04-01 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2020-03-31 |
| 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 | 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 | 2020-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-31 |