Brand Name | SPIRIT SELECT |
Type of Device | BED, AC-POWERED ADJUSTABLE HOSPITAL |
Manufacturer (Section D) |
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS |
1020 adelaide st. s. |
N6E 1R6 |
CA N6E 1R6 |
|
Manufacturer (Section G) |
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS |
1020 adelaide st. s. |
|
N6E 1R6 |
CA
N6E 1R6
|
|
Manufacturer Contact |
rita
moffitt
|
3800 east centre avenue |
portage, MI 49002
|
2693292100
|
|
MDR Report Key | 4752462 |
MDR Text Key | 22058271 |
Report Number | 3006433555-2015-00022 |
Device Sequence Number | 1 |
Product Code |
FNL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/08/2015 |
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 |
Other
|
Device Catalogue Number | 5700000000 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/08/2015
|
Initial Date FDA Received | 05/06/2015 |
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 |