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 1 R6 |
CA N6E 1R6 |
|
Manufacturer (Section G) |
STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS |
1020 adelaide st. s. |
|
N6E 1 R6 |
CA
N6E 1R6
|
|
Manufacturer Contact |
mary
klaver
|
3800 east centre avenue |
portage, MI 49002
|
2693292100
|
|
MDR Report Key | 7499387 |
MDR Text Key | 107838318 |
Report Number | 3006433555-2018-00109 |
Device Sequence Number | 1 |
Product Code |
FNL
|
UDI-Device Identifier | 07613327284546 |
UDI-Public | 07613327284546 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/09/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/09/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | 5700000000 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 04/19/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/17/2017 |
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 |
|
|