Brand Name | RAD-97 PULSE CO-OXIMETER |
Type of Device | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
Manufacturer (Section D) |
MASIMO - 15750 ALTON PKWY |
15750 alton pkwy |
irvine CA 92618 |
|
Manufacturer (Section G) |
MASIMO - MEXICALI |
industrial vallera de mexicali calzada del oro, no.2001 |
|
mexicali, baja california 21600 |
MX
21600
|
|
Manufacturer Contact |
tahereh
sedighi
|
15750 alton pkwy |
irvine, CA 92618
|
9492977862
|
|
MDR Report Key | 17848725 |
MDR Text Key | 324680502 |
Report Number | 3019388613-2023-00239 |
Device Sequence Number | 1 |
Product Code |
MWI
|
UDI-Device Identifier | 00843997012317 |
UDI-Public | 00843997012317 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K170168 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
09/06/2023 |
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 Model Number | 27573 |
Device Catalogue Number | 9738 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/06/2023
|
Initial Date FDA Received | 09/29/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/27/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|