Brand Name | ACHIEVA 1.5T NEW |
Type of Device | ACHIEVA 1.5T NEW |
Manufacturer (Section D) |
PHILIPS ELECTRONICS NEDERLAND B.V. |
veenpluis 6 |
best 5684 PC |
NL 5684 PC |
|
MDR Report Key | 9749763 |
MDR Text Key | 184276118 |
Report Number | 3003768277-2020-01001 |
Device Sequence Number | 1 |
Product Code |
LNH
|
UDI-Device Identifier | 00884838004108 |
UDI-Public | 884838004108 |
Combination Product (y/n) | N |
PMA/PMN Number | K063559 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
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 |
No Information
|
Device Model Number | ACHIEVA 1.5T |
Device Catalogue Number | 781296 |
Was Device Available for Evaluation? |
Yes
|
Distributor Facility Aware Date | 01/26/2020 |
Initial Date Manufacturer Received |
01/26/2020 |
Initial Date FDA Received | 02/25/2020 |
Supplement Dates Manufacturer Received | 01/26/2020
|
Supplement Dates FDA Received | 06/17/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|