Brand Name | ORG-9100A |
Type of Device | RECEIVER UNIT |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
NIHON KOHDEN AMERICA, INC. |
90 icon st. |
|
foothill ranch CA 92610 160 |
|
Manufacturer Contact |
|
90 icon st. |
foothill ranch, CA 92610-1601
|
|
MDR Report Key | 4143715 |
MDR Text Key | 4930579 |
Report Number | 2080783-2014-00043 |
Device Sequence Number | 1 |
Product Code |
DRG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Source Type |
Unknown |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
08/07/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | ORG-9100A |
Device Catalogue Number | ORG-9100A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 08/07/2014 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/12/2014 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/12/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
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