MAUDE report
MAUDE report 15564: GENERAL ELECTRIC MRI UNIT
Other · received Jul 20, 1994 · G.E. MEDICAL SYSTEMS
Key facts
| MDR report key | 15564 |
|---|---|
| Report number | 15564 |
| Event type | Other |
| Brand name | GENERAL ELECTRIC MRI UNIT |
| Model number | SIGNA 1.5 TESLA MRI UNIT |
| Manufacturer | G.E. MEDICAL SYSTEMS |
| Date received by FDA | Jul 20, 1994 |
| Report date | May 18, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- None Injury reports for this brand
- Yes Adverse event flagged
- No Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: