Brand Name | ICS INFINITY CENTRAL STATION |
Type of Device | PHYSIOLOGICAL MONITORING SYSTEMS |
Manufacturer (Section D) |
DRAEGER MEDICAL SYSTEMS, INC |
3135 quarry road |
telford PA |
|
Manufacturer (Section G) |
DRAEGER MEDICAL SYSTEMS, INC |
3135 quarry road |
|
telford PA |
|
Manufacturer Contact |
|
3135 quarry road |
telford, PA
|
9784470587
|
|
MDR Report Key | 18552587 |
MDR Text Key | 333362433 |
Report Number | 1220063-2024-00008 |
Device Sequence Number | 1 |
Product Code |
MHX
|
UDI-Device Identifier | 04049098001878 |
UDI-Public | (01)04049098001878(11)211102(93)MS26800-47 |
Combination Product (y/n) | N |
PMA/PMN Number | K061379 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/08/2024 |
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 | MS32504 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/08/2024
|
Initial Date FDA Received | 01/22/2024 |
Supplement Dates Manufacturer Received | 01/08/2024
|
Supplement Dates FDA Received | 05/08/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/02/2021 |
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 Outcome(s) |
Other;
|