Brand Name | HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION |
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 9706 |
|
Manufacturer (Section G) |
PHYSIO-CONTROL, INC |
11811 willows road ne |
po box 97006 |
redmond WA 98073 9706 |
|
Manufacturer Contact |
|
MDR Report Key | 4998469 |
MDR Text Key | 22811318 |
Report Number | 3015876-2015-00972 |
Device Sequence Number | 1 |
Product Code |
LDD
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K895379 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Report Date |
07/16/2015 |
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 | 3010901 |
Device Lot Number | 1502 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/09/2015 |
Is the Reporter a Health Professional? |
No
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/12/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |