Brand Name | RD SET NEO SPO2, PR, PI, PVI NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR |
Type of Device | OXIMETER |
Manufacturer (Section D) |
MASIMO CORPORATION |
52 discovery |
irvine CA 92618 |
|
MDR Report Key | 13513711 |
MDR Text Key | 285473343 |
Report Number | 13513711 |
Device Sequence Number | 1 |
Product Code |
DQA
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/04/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/11/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | 4003 |
Device Lot Number | MULTPLE, UNKNOWN (21N2A) |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/04/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/11/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|