Brand Name | HIGH FLOW INSUFFLATION UNIT |
Type of Device | HIGH FLOW INSUFFLATION UNIT |
Manufacturer (Section D) |
SHIRAKAWA OLYMPUS CO., LTD |
3-1 okamiyama |
odakura, nishigo-mura |
nishishirakawa-gun, fukushima 961-8 061 |
JA 961-8061 |
|
Manufacturer (Section G) |
SHIRAKAWA OLYMPUS CO., LTD |
3-1 okamiyama |
odakura, nishigo-mura |
nishishirakawa-gun, fukushima 961-8 061 |
JA
961-8061
|
|
Manufacturer Contact |
kazutaka
matsumoto
|
2951 ishikawa-cho |
hachioji-shi, tokyo-to 192-8-507
|
JA
192-8507
|
426425177
|
|
MDR Report Key | 11782119 |
MDR Text Key | 275993780 |
Report Number | 8010047-2021-05915 |
Device Sequence Number | 1 |
Product Code |
HIF
|
UDI-Device Identifier | 04953170324147 |
UDI-Public | 04953170324147 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K122180 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Relabeling |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
05/06/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | UHI-4 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/21/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/15/2021 |
Initial Date FDA Received | 05/06/2021 |
Supplement Dates Manufacturer Received | 05/28/2021 12/28/2023 05/06/2024
|
Supplement Dates FDA Received | 06/10/2021 01/09/2024 05/06/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/27/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | Z-0075-2024 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|