Brand Name | ASSURE WEARABLE CARDIOVERTER DEFIBRILLATOR |
Type of Device | WEARABLE AUTOMATED EXTERNAL DEFIBRILLATOR |
Manufacturer (Section D) |
KESTRA MEDICAL TECHNOLOGIES, INC. |
3933 lake washington blvd ne |
ste 200 |
kirkland WA 98033 |
|
Manufacturer (Section G) |
KESTRA MEDICAL TECHNOLOGIES, INC. |
3933 lake washington blvd ne |
ste 200 |
kirkland WA 98033 |
|
Manufacturer Contact |
jay
wiese
|
3933 lake washington blvd ne |
ste 200 |
kirkland, WA 98033
|
2069701994
|
|
MDR Report Key | 18360480 |
MDR Text Key | 331204864 |
Report Number | 3015185344-2023-00262 |
Device Sequence Number | 1 |
Product Code |
MVK
|
UDI-Device Identifier | 00840241600238 |
UDI-Public | (01)00840241600238(11)230818 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P200037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
12/19/2023 |
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 |
Lay User/Patient
|
Device Model Number | 80014-002 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/19/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/18/2023 |
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 |
Patient Age | 75 YR |
Patient Sex | Female |
Patient Weight | 105 KG |