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 |
|
Manufacturer (Section G) |
NIHON KOHEN ORANGEMED, INC. |
1800 e. wilshire ave. |
|
santa ana CA 92705 |
|
Manufacturer Contact |
sheryl
higgins
|
1800 e. wilshire ave. |
santa ana, CA 92705
|
949502644
|
|
MDR Report Key | 11309433 |
MDR Text Key | 232548103 |
Report Number | 3014631252-2021-00004 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 00843685100012 |
UDI-Public | 00843685100012 |
Combination Product (y/n) | Y |
Reporter Country Code | SP |
PMA/PMN Number | K181695 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/25/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/10/2021 |
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 | 03/18/2021 |
Was the Report Sent to FDA? |
No
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/16/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 77 YR |
Patient Weight | 90 |