Brand Name | INVOS |
Type of Device | OXIMETER, TISSUE SATURATION |
Manufacturer (Section D) |
JABIL CIRCUIT(SHANGHAI) LTD |
no 600 tian lin rd |
shanghai 20023 |
CN 20023 |
|
Manufacturer (Section G) |
JABIL CIRCUIT(SHANGHAI) LTD |
no 600 tian lin rd |
|
shanghai 20023 |
CN
20023
|
|
Manufacturer Contact |
avi
kluger
|
5920 longbow drive |
boulder, CO 80301
|
3035306582
|
|
MDR Report Key | 9293697 |
MDR Text Key | 165547886 |
Report Number | 2936999-2019-00926 |
Device Sequence Number | 1 |
Product Code |
MUD
|
UDI-Device Identifier | 10884521185890 |
UDI-Public | 10884521185890 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K091224 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/07/2019 |
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 | DS5100C-PA |
Device Catalogue Number | DS5100C-PA |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/29/2019
|
Initial Date FDA Received | 11/07/2019 |
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 |