Brand Name | ABL800 FLEX |
Type of Device | ABL800 FLEX |
Manufacturer (Section D) |
RADIOMETER MEDICAL APS |
aakandevej 21 |
broenshoej, 2700 |
DA 2700 |
|
Manufacturer (Section G) |
RADIOMETER MEDICAL APS |
aakandevej 21 |
|
broenshoej, 2700 |
DA
2700
|
|
Manufacturer Contact |
tom
engdahl
|
aakandevej 21 |
broenshoej, 2700
|
DA
2700
|
|
MDR Report Key | 12486644 |
MDR Text Key | 271886885 |
Report Number | 3002807968-2021-00039 |
Device Sequence Number | 1 |
Product Code |
CHL
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K043218 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/21/2022 |
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 |
Health Professional
|
Device Model Number | 393-800 |
Device Catalogue Number | 393-800 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/02/2021 |
Initial Date FDA Received | 09/17/2021 |
Supplement Dates Manufacturer Received | 10/25/2021 03/25/2022
|
Supplement Dates FDA Received | 11/23/2021 04/21/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|