Brand Name | GF-210RA |
Type of Device | MULTI-GAS UNIT |
Manufacturer (Section D) |
NIHON KOHDEN CORPORATION |
attn: shama mooman |
1-31-4 nishiochia |
shinjuku-ku, tokyo 161-8 560 |
JA 161-8560 |
|
Manufacturer (Section G) |
NIHON KOHDEN TOMIOKA CORPORATION |
attn: shama mooman |
1-1 tajino |
tomioka city, gunma 370-2 314 |
JA
370-2314
|
|
Manufacturer Contact |
shama
mooman
|
safety mgmt dept, quality mgmt |
seibu bldg 2, 4th floor 1-11-2 |
kusunokidai tokorozawa, saitama 359-8-580
|
JA
359-8580
|
|
MDR Report Key | 10454908 |
MDR Text Key | 204407553 |
Report Number | 8030229-2020-00481 |
Device Sequence Number | 1 |
Product Code |
CCK
|
UDI-Device Identifier | 04931921106891 |
UDI-Public | 04931921106891 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K110594 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
08/26/2020,02/28/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/26/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | GF-210RA |
Device Catalogue Number | GF-210RA |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/14/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/26/2020 |
Distributor Facility Aware Date | 07/28/2020 |
Device Age | 62 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/26/2020 |
Date Manufacturer Received | 02/23/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/03/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|