Brand Name | RADIUS PPG NEO |
Type of Device | OXIMETER |
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 |
matofa
fautua
|
15750 alton pkwy |
irvine, CA 92618
|
9498223661
|
|
MDR Report Key | 13389543 |
MDR Text Key | 285060187 |
Report Number | 3019388613-2022-00032 |
Device Sequence Number | 1 |
Product Code |
DQA
|
UDI-Device Identifier | 10843997014684 |
UDI-Public | 10843997014684 |
Combination Product (y/n) | N |
Reporter Country Code | NO |
PMA/PMN Number | K183697 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
01/04/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/28/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/01/2022 |
Device Model Number | 4585 |
Device Catalogue Number | 4585 |
Device Lot Number | E20EA85 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/04/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/09/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |