Brand Name | LIFEPAK 15 DEFIBRILLATOR/MONITOR |
Type of Device | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) |
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 | 11995345 |
MDR Text Key | 256157689 |
Report Number | 0003015876-2021-01231 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00883873871690 |
UDI-Public | 00883873871690 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P160026 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
06/14/2021 |
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 |
Health Professional
|
Device Model Number | 15 |
Device Catalogue Number | 99577-001957 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/26/2021 |
Initial Date Manufacturer Received |
05/26/2021 |
Initial Date FDA Received | 06/14/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/26/2020 |
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 |