Brand Name | JAUNDICE JM105 |
Type of Device | JAUNDICE METER/BILIRUBINOMETER |
Manufacturer (Section D) |
DRAEGER MEDICAL SYSTEMS INC |
6 tech drive |
andover MA |
|
Manufacturer (Section G) |
DRAEGER MEDICAL SYSTEMS, INC |
3135 quarry road |
|
telford PA |
|
Manufacturer Contact |
|
3135 quarry road |
telford, PA
|
9784828529
|
|
MDR Report Key | 18777815 |
MDR Text Key | 337311392 |
Report Number | 2510954-2024-00004 |
Device Sequence Number | 1 |
Product Code |
MQM
|
Combination Product (y/n) | N |
PMA/PMN Number | K133175 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
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 Catalogue Number | MU20105 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/11/2024
|
Initial Date FDA Received | 02/26/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/13/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Age | 4 DA |
Patient Race | White |
|
|