Brand Name | LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES |
Type of Device | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) |
Manufacturer (Section D) |
PHYSIO-CONTROL, INC |
11811 willows road ne - po box |
redmond WA 98073 9706 |
|
Manufacturer (Section G) |
PHYSIO-CONTROL, INC |
11811 willows road ne - po box |
|
redmond WA 98073 9706 |
|
Manufacturer Contact |
|
MDR Report Key | 7156242 |
MDR Text Key | 96128330 |
Report Number | 3015876-2017-01678 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K102972 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
02/01/2018 |
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 Catalogue Number | VLP12-02-006483 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/04/2018 |
Is the Reporter a Health Professional? |
Yes
|
Device Age | 10 YR |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
12/11/2017 |
Initial Date FDA Received | 12/30/2017 |
Supplement Dates Manufacturer Received | 01/11/2018
|
Supplement Dates FDA Received | 02/01/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/05/2007 |
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 |
Patient Age | 56 YR |