Brand Name | SYSTEM 2000 |
Manufacturer (Section D) |
ARJO HOSP. EQUIPMENT AB |
verkstadsvagen 5 |
eslov 2412 1 |
SW 24121 |
|
Manufacturer (Section G) |
ARJO, INC. |
50 north gary ave., suite a |
|
roselle IL 60172 168 |
|
Manufacturer Contact |
|
50 north gary ave., suite a |
roselle, IL 60172-1684
|
|
MDR Report Key | 3610907 |
MDR Text Key | 4170870 |
Report Number | 1419652-2014-00008 |
Device Sequence Number | 1 |
Product Code |
ILM
|
Reporter Country Code | EI |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/12/2013 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/10/2014 |
Distributor Facility Aware Date | 12/12/2013 |
Device Age | 13 NA |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/10/2014 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 01/14/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 8 YR |
|
|