Brand Name | LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR |
Type of Device | DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) |
Manufacturer (Section D) |
PHYSIO-CONTROL, INC |
11811 willows road ne |
po box 97006 |
redmond WA 98073 970 |
|
Manufacturer (Section G) |
PHYSIO-CONTROL, INC |
11811 willows road ne |
po box 97006 |
redmond WA 98073 970 |
|
Manufacturer Contact |
|
MDR Report Key | 4194314 |
MDR Text Key | 4961912 |
Report Number | 3015876-2014-01259 |
Device Sequence Number | 1 |
Product Code |
LDD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K063119 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup,Followup |
Report Date |
09/29/2014 |
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 | 20 |
Device Catalogue Number | 3202487 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/03/2014 |
Is the Reporter a Health Professional? |
Yes
|
Device Age | 11 YR |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
12/30/2014 |
Initial Date FDA Received | 10/22/2014 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 11/20/2014 01/07/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/26/2003 |
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 |