Brand Name | ASSY, MAIH, 2.7 DIA, 7 FT, W/SWITCH, 100-240V, PAC |
Type of Device | INTERNAL HANDLE |
Manufacturer (Section D) |
ZOLL MEDICAL CORPORATION |
269 mill road |
chelmsford MA 01824 |
|
Manufacturer Contact |
|
269 mill road |
chelmsford, MA 01824
|
9784219552
|
|
MDR Report Key | 15496805 |
MDR Text Key | 300707010 |
Report Number | 1220908-2022-03597 |
Device Sequence Number | 1 |
Product Code |
LDD
|
UDI-Device Identifier | 00847946022839 |
UDI-Public | 00847946022839 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/07/2022 |
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 | 1011-0141-03 |
Device Catalogue Number | 1011-0141-03 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/07/2022 |
Initial Date FDA Received | 09/28/2022 |
Supplement Dates Manufacturer Received | 09/07/2022
|
Supplement Dates FDA Received | 10/31/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/01/2021 |
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 |
|
|