Brand Name | UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM |
Type of Device | MANAGEMENT AND MONITOR SYSTEM |
Manufacturer (Section D) |
ZOLL MANUFACTURING CORPORATION |
121 gamma drive |
pittsburgh PA 15238 |
|
Manufacturer (Section G) |
ZOLL MANUFACTURING CORPORATION |
121 gamma drive |
|
pittsburgh PA |
|
Manufacturer Contact |
zoll mfg
corporation
|
121 gamma drive |
pittsburgh, PA 15238
|
|
MDR Report Key | 16134007 |
MDR Text Key | 307042151 |
Report Number | 3008642652-2023-00338 |
Device Sequence Number | 1 |
Product Code |
MHX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K172510 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/10/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM |
Initial Date Manufacturer Received |
12/15/2022 |
Initial Date FDA Received | 01/10/2023 |
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 |