Brand Name | ASSY,MAIH,2.0 DIA, W/SWITCH, 100-120VONLY, PACKAGE |
Type of Device | INTERNAL PADDLE |
Manufacturer (Section D) |
ZOLL MEDICAL CORPORATION |
269 mill road |
chelmsford MA 01824 |
|
Manufacturer Contact |
|
269 mill road |
chelmsford, MA 01824
|
9784219552
|
|
MDR Report Key | 6855326 |
MDR Text Key | 85652418 |
Report Number | 1220908-2017-02151 |
Device Sequence Number | 1 |
Product Code |
LDD
|
UDI-Device Identifier | 00847946022365 |
UDI-Public | 00847946022365 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/21/2017 |
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 | 1011-0139-05 |
Device Catalogue Number | 8011-0139-05 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/18/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/21/2017
|
Initial Date FDA Received | 09/11/2017 |
Supplement Dates Manufacturer Received | 08/21/2017
|
Supplement Dates FDA Received | 12/27/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/01/2016 |
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 | 78 YR |
|
|