Brand Name | OASIS |
Type of Device | MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
Manufacturer (Section D) |
HITACHI LTD, HEALTHCARE BUSINESS UNIT |
2-1 shintoyofuta |
kashiwa-shi, chiba-ken 277-0 804 |
JA 277-0804 |
|
Manufacturer (Section G) |
HITACHI LTD. HEALTHCARE BUSINESS UNIT |
2-1 shintoyofuta |
|
kashiwa-shi, chiba-ken 277-0 804 |
JA
277-0804
|
|
Manufacturer Contact |
douglas
thistlethwaite
|
1959 summit commerce park |
twinsburg, OH 44087
|
3304251313
|
|
MDR Report Key | 7638992 |
MDR Text Key | 112372928 |
Report Number | 8030405-2018-00003 |
Device Sequence Number | 1 |
Product Code |
LNH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K093044 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Radiologic Technologist
|
Type of Report
| Initial |
Report Date |
05/29/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Radiologic Technologist
|
Device Model Number | OASIS |
Device Catalogue Number | N/A |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/29/2018 |
Initial Date FDA Received | 06/26/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 71 YR |
Patient Weight | 118 |
|
|