Brand Name | ZOLL DEFIBRILATOR PADS |
Type of Device | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) |
Manufacturer (Section D) |
ZOLL MEDICAL CORPORATION |
269 mill road |
chelmsford MA 01824 |
|
MDR Report Key | 9117317 |
MDR Text Key | 160021307 |
Report Number | 9117317 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
07/31/2019,07/30/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 0004985 |
Device Catalogue Number | 0004985 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/31/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/25/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/25/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|