MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-07 for OASIS HIGH-FIELD BORE-LESS MR 810564 * manufactured by Hitachi Medical Systems America, Inc..
[5163934]
A non-mri compatible wheelchair was brought into the mri room during patient transport. During patient transfer from wheelchair to mri table, the wheelchair became affixed to the mri machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4416409 |
| MDR Report Key | 4416409 |
| Date Received | 2015-01-07 |
| Date of Report | 2015-01-07 |
| Date of Event | 2014-12-09 |
| Report Date | 2015-01-07 |
| Date Reported to FDA | 2015-01-07 |
| Date Reported to Mfgr | 2015-01-14 |
| Date Added to Maude | 2015-01-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OASIS HIGH-FIELD BORE-LESS MR |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNI |
| Date Received | 2015-01-07 |
| Model Number | 810564 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| Manufacturer Address | DOUGLAS THISTLETHWAITE, US AGE 1959 SUMMIT COMMERCE PARK TWINSBURG OH 44087 US 44087 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-07 |