Brand Name | SUPPORT ARM 177 |
Manufacturer (Section D) |
MAQUET CRITICAL CARE AB |
solna |
SW |
|
Manufacturer (Section G) |
MAQUET CRITICAL CARE AB |
|
|
solna S-17 154 |
SW
S-17154
|
|
Manufacturer Contact |
janice
pevide
|
45 barbour pond dr |
wayne, NJ 07470
|
9737097753
|
|
MDR Report Key | 4080314 |
MDR Text Key | 19762548 |
Report Number | 8010042-2014-00268 |
Device Sequence Number | 1 |
Product Code |
IOY
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/24/2014,05/26/2014 |
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 |
Health Professional
|
Device Catalogue Number | 6481720 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 06/23/2014 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
05/26/2014
|
Initial Date FDA Received | 07/23/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|