Brand Name | LIFE-STAT |
Type of Device | EXTERNAL CARDIAC COMPRESSOR |
Manufacturer (Section D) |
MICHIGAN INSTRUMENTS, INC |
4717 talon ct. se |
grand rapids MI 49512 |
|
Manufacturer (Section G) |
MICHIGAN INSTRUMENTS, INC. |
4717 talon ct. se |
|
grand rapids MI 49512 |
|
Manufacturer Contact |
joe
baldwin
|
4717 talon ct. se |
grand rapids, MI 49512
|
6165549696
|
|
MDR Report Key | 4504537 |
MDR Text Key | 19768957 |
Report Number | 1821850-2015-00002 |
Device Sequence Number | 1 |
Product Code |
DRM
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K073079 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Distributor |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/10/2015 |
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 |
Emergency Medical Technician
|
Device Model Number | 1008 |
Device Catalogue Number | 16000Y |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/29/2015 |
Is the Reporter a Health Professional? |
Yes
|
Device Age | 1 YR |
Initial Date Manufacturer Received |
01/29/2015 |
Initial Date FDA Received | 02/10/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/14/2013 |
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 | 35 YR |
Patient Weight | 70 |