Brand Name | TELE MX40, 1.4 GHZ, ECG AND SP02, EX |
Type of Device | TELE MX40, 1.4 GHZ, ECG AND SP02, EX |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer (Section G) |
PHILIPS NORTH AMERICA LLC |
3000 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
derek
sammarco
|
222 jacobs street |
cambridge, MA 02141
|
|
MDR Report Key | 11865353 |
MDR Text Key | 252015224 |
Report Number | 1218950-2021-10577 |
Device Sequence Number | 1 |
Product Code |
DSI
|
UDI-Device Identifier | 00884838082236 |
UDI-Public | 00884838082236 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113125 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
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 |
Other
|
Device Model Number | 865350 |
Device Catalogue Number | 865350 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 04/30/2021 |
Initial Date Manufacturer Received |
04/30/2021 |
Initial Date FDA Received | 05/21/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/10/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|