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 2020-01-15 for SIGNA PIONEER manufactured by Ge Medical Systems, Llc.
[175100131]
Age at the time of event: (b)(6). Unique identifier: (b)(4). 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. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[175100132]
It was reported that subcontractors were working to improve the shielding to the magnet scan room and were carrying a sheet of steel into the magnet room when it was attracted to the magnet. Two workers were seriously injured. Worker a sustained a laceration to his neck and was taken to surgery to close up the wound. He is recovering. The customer (b)(6) provided an updated status pending the completion of their investigation. This record will document the injuries for worker a. (2183553-2020-00002 will document the injuries for worker b).
Patient Sequence No: 1, Text Type: D, B5
[188142907]
The investigation by ge healthcare has been completed. The incident occurred due to a lack of controlled access to the scan room by the gehc pmi (project manager of install) & failure of the subcontractors to follow verbal and written safety warnings in regards to ferrous material risks. The pmi was confirmed to have received the appropriate mr safety training and the ferrous object warning signs were present at the site. The mr service safety manual and installation manual clearly define the risks associated with entering the scan room with ferrous materials when the magnet is at field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183553-2020-00001 |
| MDR Report Key | 9592535 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-22 |
| Date Mfgr Received | 2019-12-22 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2020-01-15 |
| 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 | SIGNA PIONEER |
| Generic Name | NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-01-15 |
| 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. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2020-01-15 |