Brand Name | ULTRAVIEW 1050 |
Type of Device | DETECTOR AND ALARM, ARRHYTHMIA |
Manufacturer (Section D) |
SPACELABS HEALTHCARE INC. |
35301 s.e. center st. |
snoqualmie WA 98065 |
|
MDR Report Key | 6188538 |
MDR Text Key | 62824624 |
Report Number | 6188538 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
11/15/2016,12/07/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2016 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 90369 |
Device Catalogue Number | 20099967 |
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 | 11/15/2016 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/15/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 71 YR |
|
|