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 |
jim
maatman
|
4717 talon ct. se |
grand rapids, MI 49512
|
6165549696
|
|
MDR Report Key | 7333549 |
MDR Text Key | 102325289 |
Report Number | 1821850-2016-00006 |
Device Sequence Number | 1 |
Product Code |
DRM
|
Combination Product (y/n) | N |
PMA/PMN Number | K972525 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
10/31/2016 |
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 | 16000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/04/2016 |
Was the Report Sent to FDA? |
No
|
Device Age | 5 YR |
Initial Date Manufacturer Received |
10/04/2016 |
Initial Date FDA Received | 03/13/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/23/2013 |
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 | 95 YR |