Brand Name | BED INTOUCH WITH ZOOM MOTOR |
Type of Device | BED, AC-POWERED ADJUSTABLE HOSPITAL |
Manufacturer (Section D) |
STRYKER MEDICAL-KALAMAZOO |
3800 east centre avenue |
portage MI 49002 |
|
Manufacturer (Section G) |
STRYKER MEDICAL-KALAMAZOO |
3800 east centre avenue |
|
portage MI 49002 |
|
Manufacturer Contact |
mary
klaver
|
3800 east centre avenue |
portage, MI 49002
|
2693292100
|
|
MDR Report Key | 7465690 |
MDR Text Key | 107192657 |
Report Number | 0001831750-2018-00430 |
Device Sequence Number | 1 |
Product Code |
FNL
|
UDI-Device Identifier | 07613327169232 |
UDI-Public | (01)07613327169232 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 3 |
Summary Report (Y/N) | Y |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/26/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/26/2018 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 2141 |
Device Catalogue Number | 2141000000 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 04/01/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |