Brand Name | THUMPER MODEL 1007CC |
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
|
|
MDR Report Key | 4827729 |
MDR Text Key | 5903550 |
Report Number | 1821850-2015-00004 |
Device Sequence Number | 1 |
Product Code |
DRM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K972525 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Paramedic
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
06/09/2015 |
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 |
Paramedic
|
Device Model Number | 1007CC |
Device Catalogue Number | 15350 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/18/2015 |
Is the Reporter a Health Professional? |
Yes
|
Device Age | 2 YR |
Initial Date Manufacturer Received |
05/18/2015 |
Initial Date FDA Received | 06/09/2015 |
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 | 64 YR |