Brand Name | NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM |
Type of Device | VENTILATOR, CONTINUOUS, FACILITY USE |
Manufacturer (Section D) |
NIHON KOHDEN ORANGEMED, INC. |
1800 e. wilshire ave. |
santa ana CA 92705 |
|
MDR Report Key | 10292987 |
MDR Text Key | 201878678 |
Report Number | 3014631252-2020-00002 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00843685100012 |
UDI-Public | 00843685100012 |
Combination Product (y/n) | Y |
PMA/PMN Number | K181695 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Type of Report
| Initial,Followup |
Report Date |
01/01/2005,07/17/2020 |
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 | NKV-550-U |
Device Catalogue Number | NKV-550-U |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/20/2020 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/01/2005 |
Date Report to Manufacturer | 01/10/2005 |
Initial Date Manufacturer Received |
06/18/2020 |
Initial Date FDA Received | 07/17/2020 |
Supplement Dates Manufacturer Received | 01/14/2005
|
Supplement Dates FDA Received | 09/11/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 50 YR |
Patient Weight | 72 |
|
|