Brand Name | M SERIES |
Type of Device | DEFIBRILLATOR/PACEMAKER |
Manufacturer (Section D) |
ZOLL MEDICAL CORPORATION |
chelmsford MA |
|
Manufacturer Contact |
scott
august
|
269 mill road |
chelmsford, MA 01824
|
9784219552
|
|
MDR Report Key | 3772437 |
MDR Text Key | 4358095 |
Report Number | 1220908-2014-00611 |
Device Sequence Number | 1 |
Product Code |
DSK
|
Combination Product (y/n) | N |
Reporter Country Code | SN |
PMA/PMN Number | K011865 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
02/25/2014 |
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 |
Other
|
Device Model Number | MSERIES CCT |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/25/2014
|
Initial Date FDA Received | 03/13/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2009 |
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 |
|
|