Brand Name | NIMBUS 4 |
Type of Device | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
Manufacturer (Section D) |
ARJO (SUZHOU) CO., LTD. |
no. 158 fangzhou road, sip |
suzhou, jiangsu 21502 4 |
CH 215024 |
|
Manufacturer (Section G) |
ARJO (SUZHOU) CO., LTD. |
no. 158 fangzhou road, sip |
|
suzhou, jiangsu 21502 4 |
CH
215024
|
|
Manufacturer Contact |
katarzyna
bobrow
|
ks. wawrzyniaka 2 |
komorniki 62-05-2
|
PL
62-052
|
668046472
|
|
MDR Report Key | 17169954 |
MDR Text Key | 317566091 |
Report Number | 3005619970-2023-00015 |
Device Sequence Number | 1 |
Product Code |
FNM
|
UDI-Device Identifier | 05055982782234 |
UDI-Public | (01)05055982782234(11)180325 |
Combination Product (y/n) | N |
Reporter Country Code | NS |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative,Distributor |
Reporter Occupation |
Biomedical Engineer
|
Remedial Action |
Modification/Adjustment |
Type of Report
| Initial |
Report Date |
06/21/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/21/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | 650001DAR |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/25/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | RES 87752 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|