Brand Name | RAD-8, HORIZONTAL |
Type of Device | OXIMETER |
Manufacturer (Section D) |
MASIMO - 52 DISCOVERY |
52 discovery |
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
|
52 discovery |
irvine, CA 92618
|
9496978262
|
|
MDR Report Key | 11276460 |
MDR Text Key | 230727452 |
Report Number | 3011353843-2021-00018 |
Device Sequence Number | 1 |
Product Code |
DQA
|
UDI-Device Identifier | 00843997005647 |
UDI-Public | 00843997005647 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K053269 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
01/11/2021 |
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 |
Lay User/Patient
|
Device Model Number | 22042 |
Device Catalogue Number | 9190 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/19/2021 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/11/2021 |
Initial Date FDA Received | 02/03/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/13/2017 |
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 |
|
|