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 | 8740199 |
MDR Text Key | 149378079 |
Report Number | 0003015876-2019-01114 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00883873912775 |
UDI-Public | 00883873912775 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142430 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/27/2019 |
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 | 15 |
Device Catalogue Number | 99577-001219 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/19/2019 |
Initial Date Manufacturer Received |
06/19/2019 |
Initial Date FDA Received | 06/27/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/19/2012 |
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 |