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.
[175097819]
Age at the time of event: 60s. (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
[175097820]
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 b had a cardiopulmonary arrest immediately after the accident. He was resuscitated with a defibrillator. No visible trauma was noticed at the time of the event, however it was discovered some time later that he had a cervical spine injury which required surgery. The patient was unconscious for some time, however the customer has confirmed that he has regained consciousness. The customer hasn't provided an updated status pending the completion of their investigation. This record will document the injuries for worker b. (2183553-2020-00001 will document the injuries for worker a. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183553-2020-00002 |
| MDR Report Key | 9592556 |
| 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 |