Brand Name | ZM-530PA |
Type of Device | TRANSMITTER |
Manufacturer (Section D) |
NIHON KOHDEN CORPORATION |
1-31-4 nishiochia, shinjuku-ku |
attn: shama mooman |
tokyo, 116-8 560 |
JA 116-8560 |
|
MDR Report Key | 8338028 |
MDR Text Key | 136144075 |
Report Number | 8030229-2019-00043 |
Device Sequence Number | 1 |
Product Code |
DRT
|
UDI-Device Identifier | 04931921115091 |
UDI-Public | 4931921115091 |
Combination Product (y/n) | N |
PMA/PMN Number | K043517 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Type of Report
| Initial,Followup |
Report Date |
02/13/2019 |
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 | ZM-530PA |
Device Catalogue Number | ZM-530PA |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/12/2019 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/13/2019 |
Distributor Facility Aware Date | 01/14/2019 |
Device Age | 66 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/13/2019 |
Initial Date Manufacturer Received |
01/14/2019 |
Initial Date FDA Received | 02/13/2019 |
Supplement Dates Manufacturer Received | 01/14/2019
|
Supplement Dates FDA Received | 03/15/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|