Brand Name | BEURER |
Type of Device | NEBULIZER(DIRECT PATIENT INTERFACE) |
Manufacturer (Section D) |
FOSHAN GAUNYING ELECTRONICS CO.,LTD |
no. 501, 5th floor, building 5 |
no. 51, jiang hai road, zhang |
chan cheng district,foshan, guangdong 52800 0 |
CH 528000 |
|
Manufacturer (Section G) |
FOSHAN GAUNYING ELECTRONICS CO., LTD |
no.501,5th floor,building5,no. |
51jianghairoad,zhangcha street |
chan cheng district, foshan, guangdong 52800 0 |
CH
528000
|
|
Manufacturer Contact |
ladi
lee
|
no. 501, 5th floor, building 5, no. 51, |
jianghai road, zhangcha street,chan cheng district |
foshan, guangdong 52800-0
|
CH
528000
|
|
MDR Report Key | 18499667 |
MDR Text Key | 333195217 |
Report Number | 3008395118-2023-00001 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K14211NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Administrator/Supervisor
|
Remedial Action |
Notification |
Type of Report
| Initial |
Report Date |
12/20/2023 |
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 |
Other
|
Device Model Number | IH55 |
Device Lot Number | 2020F11 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/22/2020 |
Initial Date FDA Received | 01/11/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/20/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|