Brand Name | ICU MEDICAL |
Type of Device | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
Manufacturer (Section D) |
ICU MEDICAL, INC. |
951 calle amanecer |
san clemente, CA 92673 |
|
MDR Report Key | 15833613 |
MDR Text Key | 304017068 |
Report Number | 15833613 |
Device Sequence Number | 1 |
Product Code |
DRS
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/09/2022 |
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 Model Number | 42801-35 |
Device Catalogue Number | 42801-35 |
Device Lot Number | 6033681 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/09/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/21/2022 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/21/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 19710 DA |
Patient Sex | Female |
|
|