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 | 15212354 |
MDR Text Key | 302875075 |
Report Number | 0003015876-2022-01858 |
Device Sequence Number | 1 |
Product Code |
DRX
|
UDI-Device Identifier | 00883873784945 |
UDI-Public | 00883873784945 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K943301 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
09/07/2022 |
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 | 11996 |
Device Catalogue Number | 11996-000091 |
Device Lot Number | 209423 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/21/2022
|
Initial Date FDA Received | 08/11/2022 |
Supplement Dates Manufacturer Received | 08/17/2022
|
Supplement Dates FDA Received | 09/07/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/18/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ; LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ, 32188875 |
Patient Age | 89 YR |
Patient Sex | Female |
Patient Ethnicity | Non Hispanic |
|
|