Brand Name | QUIK COMBO |
Type of Device | ELECTRODE, ELECTROCARDIOGRAPH |
Manufacturer (Section D) |
PHYSIO-CONTROL, INC. - 3015876 |
11811 willows road ne |
redmond WA 98052 |
|
Manufacturer (Section G) |
PHYSIO-CONTROL, INC. - 3015876 |
11811 willows road ne |
|
redmond WA 98052 |
|
Manufacturer Contact |
todd
bandy
|
11811 willows road ne |
redmond, WA 98052
|
4258674000
|
|
MDR Report Key | 9803188 |
MDR Text Key | 191281596 |
Report Number | 0003015876-2020-00335 |
Device Sequence Number | 1 |
Product Code |
DRX
|
UDI-Device Identifier | 00721902195037 |
UDI-Public | 00721902195037 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K943301 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/06/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/06/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/16/2022 |
Device Model Number | 11996 |
Device Catalogue Number | 11996-000090 |
Device Lot Number | 916516 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/06/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/16/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|