Brand Name | ZM-521PA |
Type of Device | TRANSMITTER |
Manufacturer (Section D) |
NIHON KOHDEN CORPORATION |
1-31-4 nishiochia, shinjuku-ku |
attn: shama mooman |
tokyo, 161-8 560 |
JA 161-8560 |
|
MDR Report Key | 11596863 |
MDR Text Key | 280472050 |
Report Number | 2080783-2021-00180 |
Device Sequence Number | 1 |
Product Code |
DRT
|
UDI-Device Identifier | 04931921115084 |
UDI-Public | 4931921115084 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial |
Report Date |
03/31/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/31/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | ZM-521PA |
Device Catalogue Number | ZM-521PA |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/31/2021 |
Distributor Facility Aware Date | 03/01/2021 |
Device Age | 34 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/31/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|